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

27 grudnia 2018 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

134

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Gore VIABAHN BX
Rozprężalny stent balonowy w chorobie okluzyjnej kości biodrowej
Urządzenie: Stenting of the Common and/or External Iliac Arteries
Balloon expandable stenting of iliac occlusive disease.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Composite of Major Adverse Events (MAEs)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Acute Procedural Success
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 30 Days
Kaplan-Meier estimate of primary patency at 30 days.
30 Days
Percentage of Participants With Primary Patency
Ramy czasowe: 9 Months
Kaplan-Meier estimate of primary patency at 9 months.
9 Months
Percentage of Participants With Primary Assisted Patency
Ramy czasowe: 30 Days
Kaplan-Meier estimate of primary assisted patency at 30 days.
30 Days
Percentage of Participants With Primary Assisted Patency
Ramy czasowe: 9 Months
Kaplan-Meier estimate of primary assisted patency at 9 months.
9 Months
Percentage of Participants With Secondary Patency
Ramy czasowe: 30 Days
Kaplan-Meier estimate of secondary patency at 30 days.
30 Days
Percentage of Participants With Secondary Patency
Ramy czasowe: 9 Months
Kaplan-Meier estimate of secondary patency at 9 months.
9 Months
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 12 Months
Kaplan-Meier estimate of primary patency at 12 months.
12 Months
Percentage of Participants With Primary Assisted Patency
Ramy czasowe: 12 Months
Kaplan-Meier estimate of primary assisted patency at 12 months.
12 Months
Percentage of Participants With Secondary Patency
Ramy czasowe: 12 Months
Kaplan-Meier estimate of secondary patency at 12 months.
12 Months
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

W.L.Gore & Associates

Śledczy

  • Główny śledczy: Jean Bismuth, MD, The Methodist Hospital Research Institute

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 lipca 2014

Zakończenie podstawowe (Rzeczywisty)

1 maja 2016

Ukończenie studiów (Rzeczywisty)

1 października 2018

Daty rejestracji na studia

Pierwszy przesłany

4 marca 2014

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 marca 2014

Pierwszy wysłany (Oszacować)

6 marca 2014

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

16 stycznia 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

27 grudnia 2018

Ostatnia weryfikacja

1 grudnia 2018

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • BES 10-07

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Tak

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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Warunki

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