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To Find the Best Dose of pVGI.1(VEGF2) to Benefit Angina Patients When Given With an Experimental Injection Catheter
This study is ongoing, but not recruiting participants.
Sponsored by: Corautus Genetics
Information provided by: Corautus Genetics
ClinicalTrials.gov Identifier: NCT00090714
  Purpose

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.


Condition Intervention Phase
Angina Pectoris
Gene Transfer: pVGI.1(VEGF2)
Phase II

MedlinePlus related topics: Angina
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Corautus Genetics:

Primary Outcome Measures:
  • Exercise Tolerance

Estimated Enrollment: 404
Study Start Date: August 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00090714

  Show 35 Study Locations
Sponsors and Collaborators
Corautus Genetics
  More Information

Study ID Numbers: VEGF2-CAD-CL-007, NIH RAC # 0301-567
Study First Received: September 2, 2004
Last Updated: April 18, 2006
ClinicalTrials.gov Identifier: NCT00090714  
Health Authority: United States: Food and Drug Administration

Keywords provided by Corautus Genetics:
DNA
Circular
Gene Therapy

Study placed in the following topic categories:
Signs and Symptoms
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Angina Pectoris
Pain
Ischemia
Chest Pain

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009