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A Study of the Gore VIABAHN BX for Treatment of Occlusive Disease in the Iliac Arteries. (VBXFLEX)

27. Dezember 2018 aktualisiert von: W.L.Gore & Associates

Evaluation of the Gore(R) Viabahn(R) Balloon Expandable Endoprosthesis (VIABAHN BX) for the Treatment of Occlusive Disease in the Common and External Iliac Arteries.

Evaluation of the Gore(R) VIABAHN BX for the treatment of arterial occlusive disease in the common and/or external iliac arteries.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This study is a prospective, multicenter, non-randomized single-arm clinical study to evaluate the safety and efficacy of the VIABAHN BX for the treatment of arterial occlusive disease in patients with de novo or restenotic lesions in the common and/or external iliac arteries.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

134

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Neuseeland
      • Auckland, Neuseeland
        • Auckland City Hospital
  • Vereinigte Staaten
    • Arizona
      • Phoenix, Arizona, Vereinigte Staaten, 85006
        • St. Luke's Medical Center
    • Connecticut
      • New Haven, Connecticut, Vereinigte Staaten, 06518
        • Yale University School Of Medicine
    • District of Columbia
      • Washington, District of Columbia, Vereinigte Staaten, 20782
        • MedStar Health Research Institute
    • Florida
      • Miami, Florida, Vereinigte Staaten, 33136
        • University of Miami
      • Miami, Florida, Vereinigte Staaten, 33176
        • Baptist Cardiac and Vascular Institute
      • Pensacola, Florida, Vereinigte Staaten, 32504
        • Coastal Vascular Institute
    • Illinois
      • Elk Grove Village, Illinois, Vereinigte Staaten, 60007
        • Cardiovascular Associates
    • Iowa
      • West Des Moines, Iowa, Vereinigte Staaten, 50266
        • Iowa Methodist Medical Center
    • Kentucky
      • Louisville, Kentucky, Vereinigte Staaten, 40202
        • University of Louisville
    • Minnesota
      • Duluth, Minnesota, Vereinigte Staaten, 55805
        • Essentia Institute for Rural Health / St Mary's Hospital
      • Plymouth, Minnesota, Vereinigte Staaten, 55422
        • North Memorial Heart & Vascular Institute
    • New Jersey
      • Morristown, New Jersey, Vereinigte Staaten, 07960
        • Advanced Vascular Associates
      • Teaneck, New Jersey, Vereinigte Staaten, 07666
        • Holy Name Medical Center
    • New York
      • Buffalo, New York, Vereinigte Staaten, 14203
        • Research Foundation SUNY Buffalo
      • New York, New York, Vereinigte Staaten, 10065
        • Cornell University
    • North Dakota
      • Fargo, North Dakota, Vereinigte Staaten, 58122
        • Sanford Clinic - Clinical Research
    • Ohio
      • Columbus, Ohio, Vereinigte Staaten, 43214
        • Ohio Health
    • Pennsylvania
      • Camp Hill, Pennsylvania, Vereinigte Staaten, 17011
        • Holy Spirit Cardiovascular Institute
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15213
        • UPMC
    • Rhode Island
      • Providence, Rhode Island, Vereinigte Staaten, 02906
        • The Miriam Hospital
    • South Carolina
      • Charleston, South Carolina, Vereinigte Staaten, 29425
        • MUSC
      • Greenville, South Carolina, Vereinigte Staaten, 29615
        • Greenville Memorial Hospital
    • Tennessee
      • Chattanooga, Tennessee, Vereinigte Staaten, 37403
        • University Surgical Associates
      • Kingsport, Tennessee, Vereinigte Staaten, 37660
        • Wellmont Holston Valley Medical Center
    • Texas
      • Houston, Texas, Vereinigte Staaten, 77030
        • The Methodist Hospital
    • Virginia
      • Norfolk, Virginia, Vereinigte Staaten, 23507
        • Sentara Medical Group

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  1. Patient is at least 18 years old;
  2. Patient is male, infertile female, or female of childbearing potential practicing an acceptable method of preventing pregnancy;
  3. Patient or legal representative is willing to give written informed consent;
  4. Patient is capable of complying with protocol requirements, including all follow-up visits;
  5. Patient has symptomatic claudication or rest pain without tissue loss (Rutherford Categories 2-4).
  6. Patient has de novo or restenotic target lesion(s) in the common and/or external iliac artery;
  7. Patient has one or more regions of stenosis ≥ 50% in the target vessel, based on visual estimate;
  8. Patient has a target vessel diameter visually estimated to be approximately between 5 mm and 13 mm;
  9. Patient has adequate ipsilateral blood flow including at least one sufficient (<50% stenotic) infrapopliteal run-off vessel not requiring intervention (per side to be intervened on).
  10. Patient has a total target lesion length visually estimated to be ≤110 mm which can be treated with a maximum of three VIABAHN BX endoprostheses;
  11. Patient has no more than two discrete ipsilateral lesions that can be treated with no more than three VIABAHN BX endoprostheses [OR] Patient has bilateral disease consisting of only one target lesion per side that can be treated with no more than a total of three VIABAHN BX endoprostheses;
  12. Patient has the device advanced across the target lesion(s) and positioned for deployment.

Exclusion Criteria:

  1. Patient has a life expectancy of less than 1 year;
  2. Patient has a known allergy to stent graft components, including stainless steel or heparin;
  3. Patient has a known intolerance to antiplatelet, anticoagulant, or thrombolytic medications that would prevent compliance with the protocol;
  4. Patient has a condition (unrelated to the study) that is expected to require indefinite, or lifelong, anticoagulation
  5. Patient has an uncorrected bleeding disorder (platelet count < 80,000/µL);
  6. Patient has severe chronic renal insufficiency (serum creatinine level > 2.5mg/dL) and not on hemodialysis;
  7. Patient has a known hypercoagulability that cannot be corrected;
  8. Patient has evidence of a blood borne infection;
  9. Patient has had vascular access/catheterization in the lower extremity within 30 days of study enrollment;
  10. Patient has had a previous or planned coronary intervention within 30 days prior to enrollment in this study or required at time of study procedure;
  11. Patient has had a previous or planned bypass surgery in the target leg, or a bypass that occurs at the time of the index procedure;
  12. Patient is currently participating in this or another investigative clinical study.
  13. Patient has a stent or stent graft located within or immediately adjacent (≤5mm) to study lesion(s);
  14. Patient has evidence of angiographically visible thrombus within or adjacent to the target lesion(s);
  15. Patient has aneurysmal dilation proximal or distal to the target lesion(s) that would interfere with the placement of the device;
  16. Patient has a target lesion requiring atherectomy or any ablative device to facilitate stent delivery;
  17. Patient has a target lesion situated in such a way that an implanted device will prevent blood flow or perfusion to the internal iliac artery if patent.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Gore VIABAHN BX
Ballonexpandierbares Stenting bei Verschlusskrankheit des Beckens
Gerät: Stenting of the Common and/or External Iliac Arteries
Balloon expandable stenting of iliac occlusive disease.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Composite of Major Adverse Events (MAEs)
Zeitfenster: 9 months
Percentage of study subjects experiencing a major adverse event (MAE) defined as: device or procedure-related death within 30 days, myocardial infarction (MI) within 30 days, target lesion revascularization (TLR) within 9 months or major amputation of the target limb within 9 months.
9 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Acute Procedural Success
Zeitfenster: Discharge
Number of subjects who experienced Acute Procedural Success defined as less than or equal to 30% residual stenosis prior to procedure completion and no device- or procedure-related SAEs before discharge.
Discharge
30-Day Clinical Success
Zeitfenster: 30 Days
Number of subjects who experienced 30-Day Clinical Success defined as an improvement of at least one Rutherford Category at the 30-day visit as compared to pre-procedure and no device- or procedure-related SAEs within 30 days of the index procedure.
30 Days
Percentage of Participants With Primary Patency
Zeitfenster: 30 Days
Kaplan-Meier estimate of primary patency at 30 days.
30 Days
Percentage of Participants With Primary Patency
Zeitfenster: 9 Months
Kaplan-Meier estimate of primary patency at 9 months.
9 Months
Percentage of Participants With Primary Assisted Patency
Zeitfenster: 30 Days
Kaplan-Meier estimate of primary assisted patency at 30 days.
30 Days
Percentage of Participants With Primary Assisted Patency
Zeitfenster: 9 Months
Kaplan-Meier estimate of primary assisted patency at 9 months.
9 Months
Percentage of Participants With Secondary Patency
Zeitfenster: 30 Days
Kaplan-Meier estimate of secondary patency at 30 days.
30 Days
Percentage of Participants With Secondary Patency
Zeitfenster: 9 Months
Kaplan-Meier estimate of secondary patency at 9 months.
9 Months
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Zeitfenster: 30 Days
Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 30 days.
30 Days
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Zeitfenster: 9 Months
Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 9 months.
9 Months
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
Zeitfenster: 30 Days
Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 30 days.
30 Days
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
Zeitfenster: 9 Months
Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 9 months.
9 Months
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
Zeitfenster: 30 Days
Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 30 days.
30 Days
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
Zeitfenster: 9 Months
Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 9 months.
9 Months
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
Zeitfenster: 30 Days
Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 30 days.
30 Days
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
Zeitfenster: 9 Months
Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 9 months
9 Months
Number of Participants With Change in Rutherford Category
Zeitfenster: 30 Days

Number of participants with change in Rutherford Category from pre-procedure at 30 days.

Rutherford Categories:

Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.

Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
30 Days
Number of Participants With Change in Rutherford Category
Zeitfenster: 9 Months

Number of participants with change in Rutherford Category from pre-procedure at 9 months.

Rutherford Categories:

Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.

Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
9 Months
Change in Ankle Brachial Index (ABI)
Zeitfenster: 30 Days
Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.
30 Days
Change in Ankle Brachial Index (ABI)
Zeitfenster: 9 Months
Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.
9 Months
Number of Participants With Change in Functional Status - EQ5D - Mobility
Zeitfenster: 30 Days
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Mobility) from pre-procedure at 30 days.
30 Days
Number of Participants With Change in Functional Status - EQ5D - Mobility
Zeitfenster: 9 Months
Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 9 months.
9 Months
Number of Participants With Change in Functional Status - EQ5D - Self Care
Zeitfenster: 30 Days
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Self Care) from pre-procedure at 30 days.
30 Days
Number of Participants With Change in Functional Status - EQ5D - Self Care
Zeitfenster: 9 Months
Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 9 months.
9 Months
Number of Participants With Change in Functional Status - EQ5D - Usual Activities
Zeitfenster: 30 Days
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 30 days.
30 Days
Number of Participants With Change in Functional Status - EQ5D - Usual Activities
Zeitfenster: 9 Months
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 9 months.
9 Months
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
Zeitfenster: 30 Days
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 30 days.
30 Days
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
Zeitfenster: 9 Months
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 9 months.
9 Months
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
Zeitfenster: 30 Days
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 30 days.
30 Days
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
Zeitfenster: 9 Months
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 9 months.
9 Months
Number of Participants With Change in Functional Status - EQ5D - Own Health State
Zeitfenster: 30 Days
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 30 days.
30 Days
Number of Participants With Change in Functional Status - EQ5D - Own Health State
Zeitfenster: 9 Months
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 9 months.
9 Months
Number of Participants With Improvement in Functional Status at 30 Days - Walking Improvement Questionnaire (WIQ)
Zeitfenster: 30 Days
Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 30 days.
30 Days
Number of Participants With Improvement in Functional Status 9 Months - Walking Improvement Questionnaire (WIQ)
Zeitfenster: 9 Months
Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 9 months.
9 Months
Percentage of Participants With Primary Patency
Zeitfenster: 12 Months
Kaplan-Meier estimate of primary patency at 12 months.
12 Months
Percentage of Participants With Primary Assisted Patency
Zeitfenster: 12 Months
Kaplan-Meier estimate of primary assisted patency at 12 months.
12 Months
Percentage of Participants With Secondary Patency
Zeitfenster: 12 Months
Kaplan-Meier estimate of secondary patency at 12 months.
12 Months
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Zeitfenster: 12 Months
Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 12 months.
12 Months
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Zeitfenster: 24 Months
Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 24 months.
24 Months
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Zeitfenster: 36 Months
Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 36 months.
36 Months
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
Zeitfenster: 12 Months
Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months.
12 Months
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
Zeitfenster: 24 Months
Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 24 months.
24 Months
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
Zeitfenster: 36 Months
Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 36 months.
36 Months
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
Zeitfenster: 12 Months
Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 12 months.
12 Months
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
Zeitfenster: 24 Months
Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 24 months.
24 Months
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
Zeitfenster: 36 Months
Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 36 months.
36 Months
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
Zeitfenster: 12 Months
Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 12 months
12 Months
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
Zeitfenster: 24 Months
Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 24 months
24 Months
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
Zeitfenster: 36 Months
Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 36 months
36 Months
Number of Participants With Change in Rutherford Category
Zeitfenster: 12 Months

Number of participants with change in Rutherford Category from pre-procedure at 12 months.

Rutherford Categories:

Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.

Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
12 Months
Number of Participants With Change in Rutherford Category
Zeitfenster: 24 Months

Number of participants with change in Rutherford Category from pre-procedure at 24 months.

Rutherford Categories:

Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.

Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
24 Months
Number of Participants With Change in Rutherford Category
Zeitfenster: 36 Months

Number of participants with change in Rutherford Category from pre-procedure at 36 months.

Rutherford Categories:

Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.

Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
36 Months
Change in Ankle Brachial Index (ABI)
Zeitfenster: 12 Months
Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.
12 Months
Change in Ankle Brachial Index (ABI)
Zeitfenster: 24 Months
Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.
24 Months
Change in Ankle Brachial Index (ABI)
Zeitfenster: 36 Months
Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.
36 Months
Number of Participants With Change in Functional Status - EQ5D - Mobility
Zeitfenster: 12 Months
Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 12 months.
12 Months
Number of Participants With Change in Functional Status - EQ5D - Mobility
Zeitfenster: 24 Months
Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 24 months.
24 Months
Number of Participants With Change in Functional Status - EQ5D - Mobility
Zeitfenster: 36 Months
Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 36 months.
36 Months
Number of Participants With Change in Functional Status - EQ5D - Self Care
Zeitfenster: 12 Months
Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 12 months.
12 Months
Number of Participants With Change in Functional Status - EQ5D - Self Care
Zeitfenster: 24 Months
Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 24 months.
24 Months
Number of Participants With Change in Functional Status - EQ5D - Self Care
Zeitfenster: 36 Months
Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 36 months.
36 Months
Number of Participants With Change in Functional Status - EQ5D - Usual Activities
Zeitfenster: 12 Months
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 12 months.
12 Months
Number of Participants With Change in Functional Status - EQ5D - Usual Activities
Zeitfenster: 24 Months
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 24 months.
24 Months
Number of Participants With Change in Functional Status - EQ5D - Usual Activities
Zeitfenster: 36 Months
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 36 months.
36 Months
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
Zeitfenster: 12 Months
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 12 months.
12 Months
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
Zeitfenster: 24 Months
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 24 months.
24 Months
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
Zeitfenster: 36 Months
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 36 months.
36 Months
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
Zeitfenster: 12 Months
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 12 months.
12 Months
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
Zeitfenster: 24 Months
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 24 months.
24 Months
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
Zeitfenster: 36 Months
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 36 months.
36 Months
Number of Participants With Change in Functional Status - EQ5D - Own Health State
Zeitfenster: 12 Months
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 12 months.
12 Months
Number of Participants With Change in Functional Status - EQ5D - Own Health State
Zeitfenster: 24 Months
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 24 months.
24 Months
Number of Participants With Change in Functional Status - EQ5D - Own Health State
Zeitfenster: 36 Months
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 36 months.
36 Months

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Device or Procedure-related Death
Zeitfenster: 30 Days
Number of subjects experiencing a device or procedure-related death within 30 Days - Component of primary outcome
30 Days
Myocardial Infarction (MI)
Zeitfenster: 30 Days
Number of subjects experiencing a myocardial infarction (MI) within 30 Days - Component of primary outcome
30 Days
Target Lesion Revascularization (TLR)
Zeitfenster: 9 Months
Number of subjects experiencing a target lesion revascularization (TLR) within 9 months - Component of primary outcome
9 Months
Major Amputation
Zeitfenster: 9 Months
Number of subjects experiencing a major amputation of the target limb within 9 months - Component of primary outcome
9 Months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

W.L.Gore & Associates

Ermittler

  • Hauptermittler: Jean Bismuth, MD, The Methodist Hospital Research Institute

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Juli 2014

Primärer Abschluss (Tatsächlich)

1. Mai 2016

Studienabschluss (Tatsächlich)

1. Oktober 2018

Studienanmeldedaten

Zuerst eingereicht

4. März 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. März 2014

Zuerst gepostet (Schätzen)

6. März 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Januar 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. Dezember 2018

Zuletzt verifiziert

1. Dezember 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • BES 10-07

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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