Overview

This trial is active, not recruiting.

Condition angina pectoris
Treatment pvgi.1(vegf2)
Phase phase 2
Sponsor Corautus Genetics
Start date August 2004
Trial size 404 participants
Trial identifier NCT00090714, NIH RAC # 0301-567, VEGF2-CAD-CL-007

Summary

The purpose of this study is to determine the optimum effective dose of recombinant plasmid DNA [pVGI.1(VEGF2)] gene therapy administered using an experimental cardiac direct injection catheter (Stiletto™) system needed to benefit patients with severe Angina Pectoris.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Measure
Exercise Tolerance
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Are willing and able to give informed consent - Have CCS class III or IV angina refractory to optimized medical therapy - Experience signs or symptoms of angina during the exercise tolerance test (ETT) - Have identified area(s) of reversible ischemic myocardium - Have procedurally acceptable targeted treatment zones Exclusion Criteria: - Have exercise-limited non-cardiac chest discomfort - Unwilling or unable to undergo exercise testing - Able to exercise greater than 6 minutes on the treadmill - Are candidates for conventional revascularization procedures - Are or have been enrolled within 30 days, in another experimental study - Have had the most recent angiogram more than 6 Months prior to screening - Previously received an investigational angiogenic agent - Have another disease severe enough to limit exercise test or place patient at risk - Have uncontrolled: atrial fibrillation, atrial flutter, and/or significant arrhythmias - Have evidence of left ventricular aneurysm or ventricular thrombus - Are unwilling or unable to undergo cardiac catheterization or nuclear testing procedures - Have had a Q-wave MI, within 60 days - Have severe aortic valve stenosis or have a mechanical aortic or mitral valve - Have unstable angina or an acute non-Q-wave myocardial infarction within 14 days - Have had a documented stroke or transient ischemic attack within 60 days - Are pacemaker dependent - Have a recent history of active diabetic retinopathy or age-related wet macular degeneration - Have a history of cancer within the last 5 yrs. or have current evidence of a malignant neoplasm - Have a history of alcohol or drug abuse within 90 days - Are pregnant or lactating - Have reproductive potential and are unwilling to use condoms for contraception for 1 year after treatment – both male and female - Are unable to return to the clinic for the scheduled follow-up appointments - Are taking medications which may produce an undue risk - Have areas of LV wall less than 6mm thick

Trial information was received from ClinicalTrials.gov and was last updated in April 2006.
Information provided to ClinicalTrials.gov by Corautus Genetics.