To Find the Best Dose of pVGI.1(VEGF2) to Benefit Angina Patients When Given With an Experimental Injection Catheter
Data Collection
Angina Pectoris+5
+ Cardiovascular Diseases
+ Chest Pain
Treatment Study
Summary
Study start date: August 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.404 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 35 locations
Arizona Heart Institute
Phoenix, United StatesMayo Clinic Hospital/Scottsdale
Phoenix, United StatesScripps Green Medical Center
LaJolla, United States