Angina Pectoris
Conditions
Keywords
DNA, Circular, Gene Therapy
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.
Interventions
GENETICpVGI.1(VEGF2)
Sponsors
Corautus Genetics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exercise Tolerance | — |
Countries
United States
Outcome results
None listed