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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
CryoLife, Inc.
ClinicalTrials.gov Identifier:
NCT01799811
First received: February 22, 2013
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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).


Condition
Critical Limb Ischemia
Peripheral Arterial Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Multicenter, Primary Below the Knee Bypass Evaluation With CryoVein® Cryopreserved Saphenous Vein Allograft in Patients With Critical Limb Ischemia

Resource links provided by NLM:


Further study details as provided by CryoLife, Inc.:

Primary Outcome Measures:
  • Limb Salvage [ Time Frame: Assessed for 24 months following surgery. ] [ Designated as safety issue: No ]
    Patients will undergo follow-up assessment for limb salvage.


Secondary Outcome Measures:
  • Patency [ Time Frame: 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". ] [ Designated as safety issue: No ]
    Patients with functional grafts will undergo follow-up Study evaluation via Duplex Ultrasound.


Other Outcome Measures:
  • All cause morbidity and mortality [ Time Frame: Assessed for 24 months following implant surgery. ] [ Designated as safety issue: No ]
    Data will be collected on any graft complications such as, but not limited to occlusion, bleeding complications, infection, or aneurysm. Patient survival will also be recorded.


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.


Estimated Enrollment: 50
Study Start Date: February 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
CLI patient's needing open bypass
Patients presenting with Rutherford Class 5 or 6 CLI that are being evaluated for open peripheral arterial revascularization.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01799811

Locations
United States, Arizona
Arizona Heart Institue
Phoenix, Arizona, United States, 85006
United States, Florida
Sacred Heart Hospital
Pensacola, Florida, United States, 32513
United States, Illinois
Carle Foundation Hospital
Urbana, Illinois, United States, 61801
United States, Texas
Scott & White Memorial Hospital
Temple, Texas, United States, 76508
Sponsors and Collaborators
CryoLife, Inc.
Investigators
Study Director: Scott B Capps, MS CryoLife, Inc.
  More Information

Publications:

Responsible Party: CryoLife, Inc.
ClinicalTrials.gov Identifier: NCT01799811     History of Changes
Other Study ID Numbers: AVG1201.000-M
Study First Received: February 22, 2013
Last Updated: July 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by CryoLife, Inc.:
allograft
limb salvage
patency
Cryopreserved
open bypass

Additional relevant MeSH terms:
Ischemia
Peripheral Arterial Disease
Peripheral Vascular Diseases
Pathologic Processes
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 18, 2014