Suspended

Optimum Dose of pVGI.1(VEGF2) Gene Therapy for Severe Angina Pectoris Using Stiletto™ Injection Catheter

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What is being tested

Data Collection

Who is being recruted

Angina Pectoris+7

+ Cardiovascular Diseases

+ Chest Pain

Over 18 Years
+29 Eligibility Criteria
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: January 27, 2026
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.

This study focuses on finding the best dose of a gene therapy called pVGI.1(VEGF2) for patients suffering from severe Angina Pectoris, a type of chest pain. The therapy is administered using an experimental injection catheter system known as Stiletto™. The goal is to understand how this treatment can benefit individuals dealing with this condition, potentially improving their quality of life and addressing the challenges associated with severe Angina Pectoris. During the study, participants receive the pVGI.1(VEGF2) gene therapy through the Stiletto™ catheter. The primary outcome measured is exercise tolerance, which helps evaluate the effectiveness of the treatment. This involves assessing the participants' ability to perform physical activities, providing insights into how well the therapy is working.

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: January 27, 2026
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 ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesMyocardial Ischemia

Criteria

5 inclusion criteria required to participate
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
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24 exclusion criteria prevent from participating
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
Show More Criteria

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 StatesOpen Cardiology, P.C. in Google Maps
Suspended

Arizona Heart Institute

Phoenix, United States
Suspended

Mayo Clinic Hospital/Scottsdale

Phoenix, United States
Suspended

Scripps Green Medical Center

La Jolla, United States
Suspended35 Study Centers