To Find the Best Dose of pVGI.1(VEGF2) to Benefit Angina Patients When Given With an Experimental Injection Catheter
2 other identifiers
interventional
404
1 country
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 2, 2004
CompletedFirst Posted
Study publicly available on registry
September 6, 2004
CompletedApril 20, 2006
April 1, 2006
September 2, 2004
April 18, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Exercise Tolerance
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Cardiology, P.C.
Birmingham, Alabama, 35211, United States
Arizona Heart Institute
Phoenix, Arizona, 85006, United States
Mayo Clinic Hospital/Scottsdale
Phoenix, Arizona, 85054, United States
Scripps Green Medical Center
La Jolla, California, 92037, United States
Aurora Denver Cardiology Associates
Aurora, Colorado, 80012, United States
Washington Heart
Washington D.C., District of Columbia, 20010, United States
Shands Hospital - Jacksonville, FL
Jacksonville, Florida, 32209, United States
Crawford Long Hospital
Atlanta, Georgia, 30308, United States
Fuqua Heart Center of Piedmont Hospital
Atlanta, Georgia, 30309, United States
St. Joseph Hospital of Atlanta
Atlanta, Georgia, 30342, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Evanston Northwestern Healthcare
Evanston, Illinois, 60201, United States
Midwest Heart Foundation
Lombard, Illinois, 60148, United States
Prairie Cardiovascular
Springfield, Illinois, 62701, United States
The Care Group, LLC
Indianapolis, Indiana, 46290, United States
Midwest CV Research Foundation
Davenport, Iowa, 52803, United States
Medstar Research
Towson, Maryland, 21218, United States
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, 02135-2997, United States
Borgess Research Institute
Kalamazoo, Michigan, 49048, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
Mayo Clinic Hospital/Rochester
Rochester, Minnesota, 55902, United States
Nebraska Heart Institute
Lincoln, Nebraska, 68504, United States
New York Presbyterian Hospital
New York, New York, 10021, United States
Columbia Presbyterian
New York, New York, 10032, United States
University of Rochester
Rochester, New York, 14642, United States
Durham VA Medical Center
Durham, North Carolina, 27705, United States
Oklahoma Cardiovascular Research
Oklahoma City, Oklahoma, 73120, United States
Baptist Hospital of East Tennessee
Knoxville, Tennessee, 37920, United States
Baylor University Hospital
Dallas, Texas, 75226, United States
Texas Heart Institute
Houston, Texas, 77030, United States
The Methodist Hospital
Houston, Texas, 77030, United States
Cardiovascular Associates of East Texas
Tyler, Texas, 75701, United States
Fletcher Allen Healthcare
Burlington, Vermont, 05401, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
Heart Care Milwaukee, WI
Milwaukee, Wisconsin, 53215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 2, 2004
First Posted
September 6, 2004
Study Start
August 1, 2004
Last Updated
April 20, 2006
Record last verified: 2006-04