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Prevention of Autogenous Vein Graft Failure in Peripheral Artery Bypass Procedures

NCT00041925 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1400

Last updated 2005-07-15

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy of graft pretreatment with the E2F decoy, CGT003, as compared to placebo, on the occurrence of graft failure among patients who receive autogenous vein grafts to treat chronic critical limb ischemia; on the occurrence of clinically significant graft stenosis (more than or equal to 70%); and on the incidence of critical limb ischemia (e.g., gangrene, non-healing ischemic ulcers or ischemic rest pain).

Conditions

  • Peripheral Vascular Diseases
  • Arterial Occlusive Diseases
  • Ischemia
  • Graft Occlusion, Vascular
  • Hyperplasia

Interventions

DRUG

CGT003 (E2F Duplex Decoy)

Sponsors & Collaborators

  • Anesiva, Inc.

    lead INDUSTRY

Principal Investigators

  • Todd Lorenz, M.D. · Anesiva, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-11-30
Completion
2004-11-30

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00041925 on ClinicalTrials.gov