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

Primary Purpose

Angina Pectoris

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
pVGI.1(VEGF2)
Sponsored by
Corautus Genetics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angina Pectoris focused on measuring DNA, Circular, Gene Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiology, P.C.
  • Arizona Heart Institute
  • Mayo Clinic Hospital/Scottsdale
  • Scripps Green Medical Center
  • Aurora Denver Cardiology Associates
  • Washington Heart
  • Shands Hospital - Jacksonville, FL
  • Crawford Long Hospital
  • Fuqua Heart Center of Piedmont Hospital
  • St. Joseph Hospital of Atlanta
  • Rush University Medical Center
  • Evanston Northwestern Healthcare
  • Midwest Heart Foundation
  • Prairie Cardiovascular
  • The Care Group, LLC
  • Midwest CV Research Foundation
  • Medstar Research
  • Caritas St. Elizabeth's Medical Center
  • Borgess Research Institute
  • Minneapolis Heart Institute
  • Mayo Clinic Hospital/Rochester
  • Nebraska Heart Institute
  • New York Presbyterian Hospital
  • Columbia Presbyterian
  • University of Rochester
  • Durham VA Medical Center
  • Oklahoma Cardiovascular Research
  • Baptist Hospital of East Tennessee
  • Baylor University Hospital
  • Texas Heart Institute
  • The Methodist Hospital
  • Cardiovascular Associates of East Texas
  • Fletcher Allen Healthcare
  • Swedish Medical Center
  • Heart Care Milwaukee, WI

Outcomes

Primary Outcome Measures

Exercise Tolerance

Secondary Outcome Measures

Full Information

First Posted
September 2, 2004
Last Updated
April 18, 2006
Sponsor
Corautus Genetics
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1. Study Identification

Unique Protocol Identification Number
NCT00090714
Brief Title
To Find the Best Dose of pVGI.1(VEGF2) to Benefit Angina Patients When Given With an Experimental Injection Catheter
Study Type
Interventional

2. Study Status

Record Verification Date
April 2006
Overall Recruitment Status
Unknown status
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Corautus Genetics

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris
Keywords
DNA, Circular, Gene Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
404 (false)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
pVGI.1(VEGF2)
Primary Outcome Measure Information:
Title
Exercise Tolerance

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Cardiology, P.C.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Arizona Heart Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Mayo Clinic Hospital/Scottsdale
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Scripps Green Medical Center
City
LaJolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Aurora Denver Cardiology Associates
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Washington Heart
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Shands Hospital - Jacksonville, FL
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Crawford Long Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Fuqua Heart Center of Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
St. Joseph Hospital of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Evanston Northwestern Healthcare
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Midwest Heart Foundation
City
Lombard
State/Province
Illinois
ZIP/Postal Code
60148
Country
United States
Facility Name
Prairie Cardiovascular
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
The Care Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Midwest CV Research Foundation
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
Medstar Research
City
Towson
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Caritas St. Elizabeth's Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135-2997
Country
United States
Facility Name
Borgess Research Institute
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Minneapolis Heart Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Mayo Clinic Hospital/Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Nebraska Heart Institute
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68504
Country
United States
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Columbia Presbyterian
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Durham VA Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Oklahoma Cardiovascular Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Baptist Hospital of East Tennessee
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Baylor University Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
Texas Heart Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Cardiovascular Associates of East Texas
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Fletcher Allen Healthcare
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Heart Care Milwaukee, WI
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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