이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2018년 12월 27일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

134

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 고어 VIABAHN BX
장골 폐쇄성 질환의 풍선 확장 스텐트
장치: Stenting of the Common and/or External Iliac Arteries
Balloon expandable stenting of iliac occlusive disease.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Composite of Major Adverse Events (MAEs)
기간: 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

2차 결과 측정

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

기타 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

W.L.Gore & Associates

수사관

  • 수석 연구원: Jean Bismuth, MD, The Methodist Hospital Research Institute

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2014년 7월 1일

기본 완료 (실제)

2016년 5월 1일

연구 완료 (실제)

2018년 10월 1일

연구 등록 날짜

최초 제출

2014년 3월 4일

QC 기준을 충족하는 최초 제출

2014년 3월 5일

처음 게시됨 (추정)

2014년 3월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 1월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 12월 27일

마지막으로 확인됨

2018년 12월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • BES 10-07

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

말초 동맥 질환에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Sri Lanka

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다