Cryopreserved Saphenous Vein Allograft in Patients With Critical Limb Ischemia for Peripheral Revascularization
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Peripheral Vascular Disease, Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2013 |
| End Date: | September 2016 |
Prospective, Multicenter, Primary Below the Knee Bypass Evaluation With CryoVein® Cryopreserved Saphenous Vein Allograft in Patients With Critical Limb Ischemia
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).
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).
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
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
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).
We found this trial at
7
sites
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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Scott & White Memorial Hospital When Arthur C. Scott, MD, and Raleigh R. White Jr.,...
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