Clinical trial NCT01799811: Cryopreserved Saphenous Vein Allograft in Patients With Critical Limb Ischemia for Peripheral Revascularization
Official title: Prospective, Multicenter, Primary Below the Knee Bypass Evaluation With CryoVein® Cryopreserved Saphenous Vein Allograft in Patients With Critical Limb Ischemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Limb Ischemia
Peripheral Arterial Disease
Keywords: allograft
limb salvage
patency
Cryopreserved
open bypass
Lead sponsor: Artivion Inc.
Sponsor class: INDUSTRY
First posted: 2013-02-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting with Rutherford Class 5 or 6 CLI that are being evaluated for open peripheral arterial revascularization.

Brief summary: 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: 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

Eligibility criteria: 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).

Primary outcomes:
measure: Limb Salvage
timeFrame: Assessed for 24 months following surgery.
Secondary outcomes:
measure: Patency
timeFrame: 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".
Other outcomes:
measure: All cause morbidity and mortality
timeFrame: Assessed for 24 months following implant surgery.
Locations:
city: Phoenix
country: United States
facility: Arizona Heart Institue
state: Arizona
city: Palo Alto
country: United States
facility: Veteran's Administration
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Pensacola
country: United States
facility: Sacred Heart Hospital
state: Florida
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
Study officials:
affiliation: CryoLife, Inc.
name: Scott B Capps, MS
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.