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

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Trial Conditions
  • Angina Pectoris
What is the purpose of this trial?

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.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

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

Gender: Both
Facilities
  • St. Elizabeth's Medical Center - Active, not recruiting
Trial Interventions
Genetic
  • pVGI.1(VEGF2)
Other Information

Sponsor: Corautus Genetics
Phase: Phase 2
Trial ID: NCT00090714
Volunteers:  Not Accepting Healthy Volunteers

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