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

2018年12月27日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

134

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：ゴア ヴィアバーン BX
腸骨閉塞症に対するバルーン拡張型ステント留置術
デバイス：Stenting of the Common and/or External Iliac Arteries
Balloon expandable stenting of iliac occlusive disease.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Composite of Major Adverse Events (MAEs)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Acute Procedural Success
時間枠：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
時間枠：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
時間枠：30 Days
Kaplan-Meier estimate of primary patency at 30 days.
30 Days
Percentage of Participants With Primary Patency
時間枠：9 Months
Kaplan-Meier estimate of primary patency at 9 months.
9 Months
Percentage of Participants With Primary Assisted Patency
時間枠：30 Days
Kaplan-Meier estimate of primary assisted patency at 30 days.
30 Days
Percentage of Participants With Primary Assisted Patency
時間枠：9 Months
Kaplan-Meier estimate of primary assisted patency at 9 months.
9 Months
Percentage of Participants With Secondary Patency
時間枠：30 Days
Kaplan-Meier estimate of secondary patency at 30 days.
30 Days
Percentage of Participants With Secondary Patency
時間枠：9 Months
Kaplan-Meier estimate of secondary patency at 9 months.
9 Months
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：12 Months
Kaplan-Meier estimate of primary patency at 12 months.
12 Months
Percentage of Participants With Primary Assisted Patency
時間枠：12 Months
Kaplan-Meier estimate of primary assisted patency at 12 months.
12 Months
Percentage of Participants With Secondary Patency
時間枠：12 Months
Kaplan-Meier estimate of secondary patency at 12 months.
12 Months
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Device or Procedure-related Death
時間枠：30 Days
Number of subjects experiencing a device or procedure-related death within 30 Days - Component of primary outcome
30 Days
Myocardial Infarction (MI)
時間枠：30 Days
Number of subjects experiencing a myocardial infarction (MI) within 30 Days - Component of primary outcome
30 Days
Target Lesion Revascularization (TLR)
時間枠：9 Months
Number of subjects experiencing a target lesion revascularization (TLR) within 9 months - Component of primary outcome
9 Months
Major Amputation
時間枠：9 Months
Number of subjects experiencing a major amputation of the target limb within 9 months - Component of primary outcome
9 Months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

W.L.Gore & Associates

捜査官

  • 主任研究者：Jean Bismuth, MD、The Methodist Hospital Research Institute

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2014年7月1日

一次修了 (実際)

2016年5月1日

研究の完了 (実際)

2018年10月1日

試験登録日

最初に提出

2014年3月4日

QC基準を満たした最初の提出物

2014年3月5日

最初の投稿 (見積もり)

2014年3月6日

学習記録の更新

投稿された最後の更新 (実際)

2019年1月16日

QC基準を満たした最後の更新が送信されました

2018年12月27日

最終確認日

2018年12月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • BES 10-07

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

はい

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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