Status:
COMPLETED
Cryopreserved Saphenous Vein Allograft in Patients With Critical Limb Ischemia for Peripheral Revascularization
Lead Sponsor:
CryoLife, Inc.
Conditions:
Critical Limb Ischemia
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
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 as...
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 mont...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01799811
Start Date
February 1 2013
End Date
June 1 2016
Last Update
August 19 2024
Active Locations (7)
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1
Arizona Heart Institue
Phoenix, Arizona, United States, 85006
2
Veteran's Administration
Palo Alto, California, United States, 94304
3
University of California at San Francisco
San Francisco, California, United States, 94143-0222
4
Sacred Heart Hospital
Pensacola, Florida, United States, 32513