Cryopreserved Saphenous Vein Allograft in Patients With Critical Limb Ischemia for Peripheral Revascularization

Study Overview
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Brief Summary
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The objective Study is to evaluate the short- and long-term clinical outcomes of patients receiving the CryoVein cryopreserved saphenous vein allograft (CVA) as their primary open bypass conduit to assess if there is a quantifiable correlation to time of placement as a primary bypass graft and improved long-term clinical outcomes of patients with critical limb ischemia (CLI).

Detailed Description
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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

Official Title
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Prospective, Multicenter, Primary Below the Knee Bypass Evaluation With CryoVein® Cryopreserved Saphenous Vein Allograft in Patients With Critical Limb Ischemia

Conditions
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Critical Limb Ischemia, Peripheral Arterial Disease

Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CLI patient's needing open bypass<br>Patients presenting with Rutherford Class 5 or 6 CLI that are being evaluated for open peripheral arterial revascularization. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Limb Salvage | Patients will undergo follow-up assessment for limb salvage. | Assessed for 24 months following surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency | Patients with functional grafts will undergo follow-up Study evaluation via Duplex Ultrasound. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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allograft, limb salvage, patency, Cryopreserved, open bypass