NCT00090714UnknownPhase 2
To Find the Best Dose of pVGI.1(VEGF2) to Benefit Angina Patients When Given With an Experimental Injection Catheter
Corautus Genetics35 sites in 1 country404 target enrollmentStarted: August 1, 2004Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 404
- Locations
- 35
- Primary Endpoint
- Exercise Tolerance
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Exercise Tolerance
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (35)
Loading locations...
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