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

Completed

Conditions studied: Critical Limb Ischemia, Peripheral Arterial Disease

In brief

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).

Key facts

Study ID

NCT01799811

Run by

CryoLife, Inc.

People needed

30

Starts

2013-02-01

Expected to finish

2016-06-01

Last updated by the study team

2024-08-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

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).

Where it is running

• Arizona Heart Institue — Phoenix, Arizona, United States
• Veteran's Administration — Palo Alto, California, United States
• University of California at San Francisco — San Francisco, California, United States
• Sacred Heart Hospital — Pensacola, Florida, United States
• Carle Foundation Hospital — Urbana, Illinois, United States
• University of Texas Medical Branch — Galveston, Texas, United States
• Scott & White Memorial Hospital — Temple, Texas, United States

Full record on ClinicalTrials.gov

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