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

NCT01799811 | Completed

• 1 other identifier: AVG1201.000-M
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 7

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).

Conditions

Critical Limb Ischemia; Peripheral Arterial Disease

Keywords

allograft; limb salvage; patency; Cryopreserved; open bypass

Outcome Measures

Primary Outcomes (1)

• Limb Salvage

  Patients will undergo follow-up assessment for limb salvage.

  Assessed for 24 months following surgery.

Secondary Outcomes (1)

• Patency

  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 (1)

• All cause morbidity and mortality

  Assessed for 24 months following implant surgery.

Study Arms (1)

CLI patient's needing open bypass

Patients presenting with Rutherford Class 5 or 6 CLI that are being evaluated for open peripheral arterial revascularization.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• CryoLife, Inc.: lead

Study Sites (7)

Arizona Heart Institue

Phoenix, Arizona, 85006, United States

Location

Veteran's Administration

Palo Alto, California, 94304, United States

Location

University of California at San Francisco

San Francisco, California, 94143-0222, United States

Location

Sacred Heart Hospital

Pensacola, Florida, 32513, United States

Location

Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0737, United States

Location

Scott & White Memorial Hospital

Temple, Texas, 76508, United States

Location

Related Publications (9)

• 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.

  PMID: 8411463 BACKGROUND

• 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.

  PMID: 8264053 BACKGROUND

• 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.

  PMID: 9140596 BACKGROUND

• 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.

  PMID: 8203975 BACKGROUND

• 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.

  PMID: 12844083 BACKGROUND

• 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.

  PMID: 18657383 BACKGROUND

• 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.

  PMID: 11013037 BACKGROUND

• 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.

  PMID: 20889296 BACKGROUND

• 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.

  PMID: 20347683 BACKGROUND

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.

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Scott B Capps, MS

  CryoLife, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2013
• First Posted: February 27, 2013
• Study Start: February 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)