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

Angina Pectoris Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00090714
• Other study ID #: VEGF2-CAD-CL-007
• Secondary ID: NIH RAC # 0301-5
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 2, 2004
• Last updated: April 18, 2006
• Start date: August 2004

Study information

• Verified date: April 2006
• Source: Corautus Genetics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 404
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris

Intervention

Genetic:
• pVGI.1(VEGF2)

Locations

Country	Name	City	State
United States	Crawford Long Hospital	Atlanta	Georgia
United States	Fuqua Heart Center of Piedmont Hospital	Atlanta	Georgia
United States	St. Joseph Hospital of Atlanta	Atlanta	Georgia
United States	Aurora Denver Cardiology Associates	Aurora	Colorado
United States	Cardiology, P.C.	Birmingham	Alabama
United States	Caritas St. Elizabeth's Medical Center	Boston	Massachusetts
United States	Fletcher Allen Healthcare	Burlington	Vermont
United States	Rush University Medical Center	Chicago	Illinois
United States	Baylor University Hospital	Dallas	Texas
United States	Midwest CV Research Foundation	Davenport	Iowa
United States	Durham VA Medical Center	Durham	North Carolina
United States	Evanston Northwestern Healthcare	Evanston	Illinois
United States	Texas Heart Institute	Houston	Texas
United States	The Methodist Hospital	Houston	Texas
United States	The Care Group, LLC	Indianapolis	Indiana
United States	Shands Hospital - Jacksonville, FL	Jacksonville	Florida
United States	Borgess Research Institute	Kalamazoo	Michigan
United States	Baptist Hospital of East Tennessee	Knoxville	Tennessee
United States	Scripps Green Medical Center	LaJolla	California
United States	Nebraska Heart Institute	Lincoln	Nebraska
United States	Midwest Heart Foundation	Lombard	Illinois
United States	Heart Care Milwaukee, WI	Milwaukee	Wisconsin
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	Columbia Presbyterian	New York	New York
United States	New York Presbyterian Hospital	New York	New York
United States	Oklahoma Cardiovascular Research	Oklahoma City	Oklahoma
United States	Arizona Heart Institute	Phoenix	Arizona
United States	Mayo Clinic Hospital/Scottsdale	Phoenix	Arizona
United States	Mayo Clinic Hospital/Rochester	Rochester	Minnesota
United States	University of Rochester	Rochester	New York
United States	Swedish Medical Center	Seattle	Washington
United States	Prairie Cardiovascular	Springfield	Illinois
United States	Medstar Research	Towson	Maryland
United States	Cardiovascular Associates of East Texas	Tyler	Texas
United States	Washington Heart	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Corautus Genetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise Tolerance