![]() |
|
![]() |
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsored by: |
GenVec |
Information provided by: | GenVec |
ClinicalTrials.gov Identifier: | NCT00215696 |
The primary purpose of this study is to determine whether treatment with an experimental gene therapy (BIOBYPASS®) will reduce angina in study participants by stimulating the growth of new blood vessels. This will be measured by testing whether participants are able to exercise longer without experiencing angina after treatment, as compared to before treatment.
Additionally, this study will collect information about any side effects that might be related to the treatment with the experimental therapy.
Condition | Intervention | Phase |
Moderate to Severe Angina Pectoris |
Gene Transfer: BioBypass® |
Phase II |
MedlinePlus related topics: | Angina Exercise and Physical Fitness |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of BIOBYPASS® (ADGVVEGF121.10NH) Delivered by NOGA™-GUIDED/MYOSTAR™ Catheter in “No Option” Patients With Class II-IV Stable Angina |
Estimated Enrollment: | 129 |
Study Start Date: | April 2005 |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Treated with optimal unchanged antianginal medical therapy for at least 2 months prior to the first baseline ETT. Optimal medical therapy must include the following medications (unless hemodynamic parameters or intolerance contraindicate their use):
Candidates must not be eligible for any other re-vascularization procedures. The participant and his coronary film must have been discussed with an independent cardiac surgeon and must have been denied for CABG or PTCA. Participants who are marginal or poor candidates for conventional revascularization will be considered eligible if the risks of performing a CABG or PTCA procedure outweigh the potential benefit and/or such a procedure is unlikely to offer a worthwhile clinical benefit. The criteria defining such cases may include, but may not be limited to, the following examples:
Two baseline bicycle ergometry exercise tolerance tests (ETTs) performed meeting the following criteria:
Exclusion Criteria:
Ophthalmologic conditions pertinent to proliferative retinopathy or conditions that preclude standard ophthalmologic examination.
Denmark | |||||
Skejby Sygehus, Caridology Laboratory | |||||
Århus N, Denmark, DK-8200 | |||||
Cardiovascular Laboratory 2014, The Heart Center, University hospital Rigshospitalet | |||||
Copenhagen, Denmark, 2100 | |||||
Israel, Tikva | |||||
Cardiac Catheterization Laboratories, Cardiology Department, Rabin Medical Center | |||||
Petah, Tikva, Israel, 49100 |
GenVec |
Principal Investigator: | Dr. Jens Kastrup | The Heart Center, University hospital Rigshospitalet |
Study ID Numbers: | GV-002.001 |
First Received: | September 15, 2005 |
Last Updated: | July 25, 2006 |
ClinicalTrials.gov Identifier: | NCT00215696 |
Health Authority: | Israel: Ministry of Health Pharmaceutical Department; Denmark: The Danish Medicines Agency; United Kingdom: Clinical Trials Unit, MHRA |
|
|
|
![]() |