Cryopreserved Saphenous Vein Allograft in Patients With Critical Limb Ischemia for Peripheral Revascularization (LIMBSAVE)
Prospective, Multicenter, Primary Below the Knee Bypass Evaluation With CryoVein® Cryopreserved Saphenous Vein Allograft in Patients With Critical Limb Ischemia
연구 개요
상세 설명
A minimum of 50 CVA will be implanted in enrolled patients at up to 6 participating sites. The Study will include prospective evaluations on these patients at discharge, 1, 3, 6, 9, 12, 18 and 24 months following surgery. The window for follow-up visits is ± 2 weeks for each time point. All Study patients will be expected to participate in all follow-up evaluations unless precluded by patient death.
Patient status and graft performance data will be collected on all patients consented and enrolled into the Study. The primary endpoint of the Study will be limb salvage. The secondary endpoints of the Study will include primary patency, secondary patency, morbidity and mortality per the same reporting standards.
Patient attributes (age, gender, etc.) and preoperative assessments (indication for surgery, medical history) will be summarized using descriptive statistics. Graft performance will be presented as freedom from an event endpoint (patient death, graft complication, amputation, graft explant) as calculated by the Kaplan-Meier method. Log Rank and Cox Regression will be utilized for comparison between subgroups of the patient population. Statistical software will be used to compile and analyze all submitted clinical data.
The method of data reporting may include, but is not limited to, a description of the sample population, frequency distributions of patient demographics, allograft statistics, and follow-up percentages, summary of event data, correlation analysis, and actuarial analysis
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Arizona
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Phoenix, Arizona, 미국, 85006
- Arizona Heart Institue
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California
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Palo Alto, California, 미국, 94304
- Veteran's Administration
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San Francisco, California, 미국, 94143-0222
- University of California at San Francisco
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Florida
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Pensacola, Florida, 미국, 32513
- Sacred Heart Hospital
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Illinois
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Urbana, Illinois, 미국, 61801
- Carle Foundation Hospital
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Texas
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Galveston, Texas, 미국, 77555-0737
- University of Texas Medical Branch
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Temple, Texas, 미국, 76508
- Scott & White Memorial Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patient is an acceptable candidate to receive primary open bypass on the limb receiving the CVA.
- CLI diagnosis of Rutherford Class 5 or 6.
- Tibio-peroneal trunk, Tibial or Peroneal outflow artery.
- Minimum of 1 patent run-off artery.
- Serum Creatinine < 2.4 mg/dl.
- Life expectancy > 2 years from consent.
- 18 years of age or older at the time of consent.
- Male or non-pregnant female.
- Ability to understand and provide written informed consent.
- Willing and able to attend and cooperate with the follow-up examinations.
- Able to follow Study required post-operative daily aspirin and/or other oral anticoagulation/antiplatelet regimen.
Exclusion Criteria:
- Patient currently receiving hemodialysis for end stage renal disease.
- Known hypercoaguable state.
- Known heparin allergy.
- Patients with any condition which, in the opinion of the investigator could preclude evaluation of response or completion of follow-up or affect patient safety.
- Currently being treated with an investigational device or drug (within 3 months prior to surgery).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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CLI patient's needing open bypass
Patients presenting with Rutherford Class 5 or 6 CLI that are being evaluated for open peripheral arterial revascularization.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Limb Salvage
기간: Assessed for 24 months following surgery.
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Patients will undergo follow-up assessment for limb salvage.
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Assessed for 24 months following surgery.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patency
기간: Assessed until graft failure over a period of 24 months. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months".
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Patients with functional grafts will undergo follow-up Study evaluation via Duplex Ultrasound.
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Assessed until graft failure over a period of 24 months. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months".
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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All cause morbidity and mortality
기간: Assessed for 24 months following implant surgery.
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Data will be collected on any graft complications such as, but not limited to occlusion, bleeding complications, infection, or aneurysm.
Patient survival will also be recorded.
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Assessed for 24 months following implant surgery.
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
일반 간행물
- Walker PJ, Mitchell RS, McFadden PM, James DR, Mehigan JT. Early experience with cryopreserved saphenous vein allografts as a conduit for complex limb-salvage procedures. J Vasc Surg. 1993 Oct;18(4):561-8; discussion 568-9.
- Shah RM, Faggioli GL, Mangione S, Harris LM, Kane J, Taheri SA, Ricotta JJ. Early results with cryopreserved saphenous vein allografts for infrainguinal bypass. J Vasc Surg. 1993 Dec;18(6):965-9; discussion 969-71. doi: 10.1067/mva.1993.50617.
- Leseche G, Penna C, Bouttier S, Joubert S, Andreassian B. Femorodistal bypass using cryopreserved venous allografts for limb salvage. Ann Vasc Surg. 1997 May;11(3):230-6. doi: 10.1007/s100169900039.
- Martin RS 3rd, Edwards WH, Mulherin JL Jr, Edwards WH Jr, Jenkins JM, Hoff SJ. Cryopreserved saphenous vein allografts for below-knee lower extremity revascularization. Ann Surg. 1994 Jun;219(6):664-70; discussion 670-2. doi: 10.1097/00000658-199406000-00009.
- Farber A, Major K, Wagner WH, Cohen JL, Cossman DV, Lauterbach SR, Levin PM. Cryopreserved saphenous vein allografts in infrainguinal revascularization: analysis of 240 grafts. J Vasc Surg. 2003 Jul;38(1):15-21. doi: 10.1016/s0741-5214(03)00330-6.
- Bannazadeh M, Sarac TP, Bena J, Srivastava S, Ouriel K, Clair D. Reoperative lower extremity revascularization with cadaver vein for limb salvage. Ann Vasc Surg. 2009 Jan-Feb;23(1):24-31. doi: 10.1016/j.avsg.2008.04.011. Epub 2008 Jul 26.
- Buckley CJ, Abernathy S, Lee SD, Arko FR, Patterson DE, Manning LG. Suggested treatment protocol for improving patency of femoral-infrapopliteal cryopreserved saphenous vein allografts. J Vasc Surg. 2000 Oct;32(4):731-8. doi: 10.1067/mva.2000.110049.
- Zehr BP, Niblick CJ, Downey H, Ladowski JS. Limb salvage with CryoVein cadaver saphenous vein allografts used for peripheral arterial bypass: role of blood compatibility. Ann Vasc Surg. 2011 Feb;25(2):177-81. doi: 10.1016/j.avsg.2010.07.020.
- Randon C, Jacobs B, De Ryck F, Beele H, Vermassen F. Fifteen years of infrapopliteal arterial reconstructions with cryopreserved venous allografts for limb salvage. J Vasc Surg. 2010 Apr;51(4):869-77. doi: 10.1016/j.jvs.2009.11.062.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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말초 동맥 질환에 대한 임상 시험
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C. R. Bard완전한
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Mayo Clinic초대로 등록
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University Hospital, Strasbourg, France완전한