Clinical Trials Directory

Trials / Unknown

UnknownNCT00143585

NOGA Angiogenesis Revascularization Therapy: Evaluation by RadioNuclide Imaging - The Northern Trial

Multicentre, Randomized,Double Blind,Placebo Controlled Trial of Myocardial Angiogenesis Using VEGF165, Intramyocardial Gene Delivery in Patients With Severe Angina

Status
Unknown
Phase
Phase 2 / Phase 3
Study type
Interventional
Enrollment
120 (planned)
Sponsor
Unity Health Toronto · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

To demonstrate the clinical efficacy and safety of vascular endothelial growth factor(VEGF165)when delivered by direct myocardial injection through the NOGA navigational catheter to improve myocardial perfusion in patients with severe angina pectoris for whom conventional PCI or CABG are either not possible or not ideal.Secondary objective will be to determine the effects of VEGF gene therapy on angina symptoms, patient perceived quality of life and exercise capacity

Detailed description

A multicentre, double blind, placebo controlled trial to assess efficacy of VEGF and promote myocardial angiogenesis in patients with CCS III-IV angina symptoms,treated with maximal anti anginal medications who are not amenable to or not ideal candidates for conventional revascularization.

Conditions

Interventions

TypeNameDescription
PROCEDUREintramyocardial delivery of either VEGF165 or placebo

Timeline

Start date
2002-06-01
Completion
2007-06-01
First posted
2005-09-02
Last updated
2008-07-25

Locations

7 sites across 1 country: Canada

Source: ClinicalTrials.gov record NCT00143585. Inclusion in this directory is not an endorsement.