Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

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

torstai 27. joulukuuta 2018 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

134

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Ei käytössä
  • Inventiomalli: Yksittäinen ryhmätehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Gore VIABAHN BX
Balloon laajennettava stentointi suoliluun okklusiivisessa sairaudessa
Laite: Stenting of the Common and/or External Iliac Arteries
Balloon expandable stenting of iliac occlusive disease.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Composite of Major Adverse Events (MAEs)
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Acute Procedural Success
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 30 Days
Kaplan-Meier estimate of primary patency at 30 days.
30 Days
Percentage of Participants With Primary Patency
Aikaikkuna: 9 Months
Kaplan-Meier estimate of primary patency at 9 months.
9 Months
Percentage of Participants With Primary Assisted Patency
Aikaikkuna: 30 Days
Kaplan-Meier estimate of primary assisted patency at 30 days.
30 Days
Percentage of Participants With Primary Assisted Patency
Aikaikkuna: 9 Months
Kaplan-Meier estimate of primary assisted patency at 9 months.
9 Months
Percentage of Participants With Secondary Patency
Aikaikkuna: 30 Days
Kaplan-Meier estimate of secondary patency at 30 days.
30 Days
Percentage of Participants With Secondary Patency
Aikaikkuna: 9 Months
Kaplan-Meier estimate of secondary patency at 9 months.
9 Months
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 12 Months
Kaplan-Meier estimate of primary patency at 12 months.
12 Months
Percentage of Participants With Primary Assisted Patency
Aikaikkuna: 12 Months
Kaplan-Meier estimate of primary assisted patency at 12 months.
12 Months
Percentage of Participants With Secondary Patency
Aikaikkuna: 12 Months
Kaplan-Meier estimate of secondary patency at 12 months.
12 Months
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Muut tulostoimenpiteet

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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

W.L.Gore & Associates

Tutkijat

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

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Tiistai 1. heinäkuuta 2014

Ensisijainen valmistuminen (Todellinen)

Sunnuntai 1. toukokuuta 2016

Opintojen valmistuminen (Todellinen)

Maanantai 1. lokakuuta 2018

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Tiistai 4. maaliskuuta 2014

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Keskiviikko 5. maaliskuuta 2014

Ensimmäinen Lähetetty (Arvio)

Torstai 6. maaliskuuta 2014

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 16. tammikuuta 2019

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Torstai 27. joulukuuta 2018

Viimeksi vahvistettu

Lauantai 1. joulukuuta 2018

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • BES 10-07

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Joo

Yhdysvalloissa valmistettu ja sieltä viety tuote

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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