Angina PectorisPhase 2NCT00090714
To Find the Best Dose of pVGI.1(VEGF2) to Benefit Angina Patients When Given With an Experimental Injection Catheter
A Phase 2 study testing pVGI.1(VEGF2) in people with Angina Pectoris, run by Corautus Genetics at 35 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina Pectoris
- What is being tested?
- pVGI.1(VEGF2)
- How many people
- 404 participants
- Where
- 35 sitesUnited States
- Study dates
- Aug 2004to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Crawford Long Hospital
Atlanta, Georgia, 30308
Fuqua Heart Center of Piedmont Hospital
Atlanta, Georgia, 30309
St. Joseph Hospital of Atlanta
Atlanta, Georgia, 30342
Aurora Denver Cardiology Associates
Aurora, Colorado, 80012
Cardiology, P.C.
Birmingham, Alabama, 35211
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, 02135-2997
Fletcher Allen Healthcare
Burlington, Vermont, 05401
Rush University Medical Center
Chicago, Illinois, 60612
Baylor University Hospital
Dallas, Texas, 75226
Midwest CV Research Foundation
Davenport, Iowa, 52803
Durham VA Medical Center
Durham, North Carolina, 27705
Evanston Northwestern Healthcare
Evanston, Illinois, 60201
Texas Heart Institute
Houston, Texas, 77030
The Methodist Hospital
Houston, Texas, 77030
The Care Group, LLC
Indianapolis, Indiana, 46290
Shands Hospital - Jacksonville, FL
Jacksonville, Florida, 32209
Borgess Research Institute
Kalamazoo, Michigan, 49048
Baptist Hospital of East Tennessee
Knoxville, Tennessee, 37920
Scripps Green Medical Center
La Jolla, California, 92037
Nebraska Heart Institute
Lincoln, Nebraska, 68504
Midwest Heart Foundation
Lombard, Illinois, 60148
Heart Care Milwaukee, WI
Milwaukee, Wisconsin, 53215
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
New York Presbyterian Hospital
New York, New York, 10021
Columbia Presbyterian
New York, New York, 10032
Oklahoma Cardiovascular Research
Oklahoma City, Oklahoma, 73120
Arizona Heart Institute
Phoenix, Arizona, 85006
Mayo Clinic Hospital/Scottsdale
Phoenix, Arizona, 85054
Mayo Clinic Hospital/Rochester
Rochester, Minnesota, 55902
University of Rochester
Rochester, New York, 14642
Swedish Medical Center
Seattle, Washington, 98104
Prairie Cardiovascular
Springfield, Illinois, 62701
Medstar Research
Towson, Maryland, 21218
Cardiovascular Associates of East Texas
Tyler, Texas, 75701
Washington Heart
Washington D.C., District of Columbia, 20010
About this study
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.
- Conditions
- Angina Pectoris
- Being tested
- pVGI.1(VEGF2)
- Keywords
- DNA, Circular, Gene Therapy
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pVGI.1(VEGF2)Genetic
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Tolerance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2004 (estimated)
- Study startAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 404 participants
Sponsor and investigators
- Lead sponsor
- Corautus Genetics
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090714
- Sponsor's protocol ID
- VEGF2-CAD-CL-007
- Other IDs
- NIH RAC # 0301-567
- Status last verified
- Apr 2006
- First submitted
- 2 Sep 2004
- Last updated
- 20 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Find the Best Dose of pVGI.1(VEGF2) to Benefit Angina Patients When Given With an Experimental Injection Catheter
- ClinicalTrials.gov ID
- NCT00090714
- Acronym / sponsor ID
- VEGF2-CAD-CL-007
- Conditions
- Angina Pectoris
- Keywords
- DNA, Circular, Gene Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 404 participants
- Lead sponsor
- Corautus GeneticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- First posted
- 6 Sep 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pVGI.1(VEGF2) | Genetic | – |
Primary outcome
Exercise Tolerance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pVGI.1(VEGF2) in people with Angina Pectoris, run by Corautus Genetics at 35 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Tolerance. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2006.