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

Corautus Genetics

Status and phase

Unknown

Phase 2

Conditions

Angina Pectoris

Treatments

Genetic: pVGI.1(VEGF2)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00090714

NIH RAC # 0301-567

VEGF2-CAD-CL-007

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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