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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by Corautus Genetics.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Corautus Genetics
ClinicalTrials.gov Identifier:
NCT00090714
First received: September 2, 2004
Last updated: April 18, 2006
Last verified: April 2006
  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
Genetic: pVGI.1(VEGF2)
Phase 2

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090714

  Show 35 Study Locations
Sponsors and Collaborators
Corautus Genetics
  More Information

No publications provided

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

Keywords provided by Corautus Genetics:
DNA
Circular
Gene Therapy

Additional relevant MeSH terms:
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014