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

February 22, 2013
July 22, 2014
February 2013
September 2016   (final data collection date for primary outcome measure)
Limb Salvage [ Time Frame: Assessed for 24 months following surgery. ] [ Designated as safety issue: No ]
Patients will undergo follow-up assessment for limb salvage.
Same as current
Complete list of historical versions of study NCT01799811 on ClinicalTrials.gov Archive Site
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.
Same as current
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.
Same as current
 
Cryopreserved Saphenous Vein Allograft in Patients With Critical Limb Ischemia for Peripheral Revascularization
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).

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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.

Non-Probability Sample

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

  • Critical Limb Ischemia
  • Peripheral Arterial Disease
Not Provided
CLI patient's needing open bypass
Patients presenting with Rutherford Class 5 or 6 CLI that are being evaluated for open peripheral arterial revascularization.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
50
September 2016
September 2016   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01799811
AVG1201.000-M
No
CryoLife, Inc.
CryoLife, Inc.
Not Provided
Study Director: Scott B Capps, MS CryoLife, Inc.
CryoLife, Inc.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP