Suspended

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

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What is being tested

Data Collection

Who is being recruted

Angina Pectoris+5

+ Cardiovascular Diseases

+ Chest Pain

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 2004
See protocol details

Summary

Principal SponsorCorautus Genetics
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

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.

Official TitleTo Find the Best Dose of pVGI.1(VEGF2) to Benefit Angina Patients When Given With an Experimental Injection Catheter 
NCT00090714
Principal SponsorCorautus Genetics
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

404 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Angina PectorisCardiovascular DiseasesChest PainHeart DiseasesNeurologic ManifestationsPainVascular DiseasesMyocardial Ischemia

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

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

Suspended

Cardiology, P.C.

Birmingham, United StatesSee the location
Suspended

Arizona Heart Institute

Phoenix, United States
Suspended

Mayo Clinic Hospital/Scottsdale

Phoenix, United States
Suspended

Scripps Green Medical Center

LaJolla, United States
Suspended35 Study Centers