Status:
UNKNOWN
To Find the Best Dose of pVGI.1(VEGF2) to Benefit Angina Patients When Given With an Experimental Injection Catheter
Lead Sponsor:
Corautus Genetics
Conditions:
Angina Pectoris
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 (Sti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
404 Patients enrolled
Trial Details
Trial ID
NCT00090714
Start Date
August 1 2004
Last Update
April 20 2006
Active Locations (35)
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1
Cardiology, P.C.
Birmingham, Alabama, United States, 35211
2
Arizona Heart Institute
Phoenix, Arizona, United States, 85006
3
Mayo Clinic Hospital/Scottsdale
Phoenix, Arizona, United States, 85054
4
Scripps Green Medical Center
La Jolla, California, United States, 92037