Cryopreserved Saphenous Vein Allograft in Patients With Critical Limb Ischemia for Peripheral Revascularization (LIMBSAVE)
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).
Critical Limb Ischemia
Peripheral Arterial Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prospective, Multicenter, Primary Below the Knee Bypass Evaluation With CryoVein® Cryopreserved Saphenous Vein Allograft in Patients With Critical Limb Ischemia|
- Limb Salvage [ Time Frame: Assessed for 24 months following surgery. ] [ Designated as safety issue: No ]Patients will undergo follow-up assessment for limb salvage.
- Patency [ Time Frame: 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". ] [ Designated as safety issue: No ]Patients with functional grafts will undergo follow-up Study evaluation via Duplex Ultrasound.
- All cause morbidity and mortality [ Time Frame: Assessed for 24 months following implant surgery. ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples With DNA
During the Study follow-up period, a patient may present with an event requiring an open surgical revision, surgical explant or limb amputation on the (allograft) recipient limb. At the time of related planned intervention a tissue sample of the affected area of the allograft may be obtained and, if so, will placed into 10% buffered formalin solution and returned to CryoLife for histologic analysis.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
CLI patient's needing open bypass
Patients presenting with Rutherford Class 5 or 6 CLI that are being evaluated for open peripheral arterial revascularization.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01799811
|United States, Arizona|
|Arizona Heart Institue|
|Phoenix, Arizona, United States, 85006|
|United States, California|
|Palo Alto, California, United States, 94304|
|University of California at San Francisco|
|San Francisco, California, United States, 94143-0222|
|United States, Florida|
|Sacred Heart Hospital|
|Pensacola, Florida, United States, 32513|
|United States, Illinois|
|Carle Foundation Hospital|
|Urbana, Illinois, United States, 61801|
|United States, Texas|
|University of Texas Medical Branch|
|Galveston, Texas, United States, 77555-0737|
|Scott & White Memorial Hospital|
|Temple, Texas, United States, 76508|
|Study Director:||Scott B Capps, MS||CryoLife, Inc.|