To Find the Best Dose of pVGI.1(VEGF2) to Benefit Angina Patients When Given With an Experimental Injection Catheter

Study Overview
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Brief Summary
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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.

Conditions
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Angina Pectoris

Intervention / Treatment
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* Genetic: pVGI.1(VEGF2)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: pVGI.1(VEGF2)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Tolerance |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DNA, Circular, Gene Therapy