Peripheral Stimulation Device to Improve Coronary Flow Reserve in Coronary Artery Disease
NCT01853410 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2015-11-26
Summary
The purpose of the PERCCAD Study is to investigate the effect of the gekoTM device (a non-invasive calf muscle stimulator approved for use to improve blood flow by Health Canada) on coronary blood flow in order to assess its potential role as a therapeutic modality for the treatment of symptomatic coronary artery disease (CAD). This will occur in patients already undergoing coronary angiography and percutaneous coronary intervention (PCI) as part of their usual medical care. Further, the investigators will also assess the overall effect on blood flow in the body using non-invasive techniques. The primary objective of the PERCCAD study is to assess the effect of the gekoTM device on coronary blood flow in patients with symptomatic CAD who are undergoing invasive angiographic assessment and management with PCI. This evaluation of the gekoTM device is to be performed at the time of the patient's already planned invasive assessment and management so that invasive data can be collected without exposing the patient to risks other than those already associated with their planned procedure and usual clinical care. The secondary objective of the study is to assess the effect of muscle stimulation with the gekoTM device on endothelial function and peripheral blood flow measured via non-invasive techniques.
Conditions
- Coronary Artery Disease
- Ischemic Disease
Interventions
- DEVICE
-
gekoTM
Sponsors & Collaborators
-
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
lead OTHER
Principal Investigators
-
Shahar Lavi, MD · London Health Sciences Centre
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-07-31
- Primary Completion
- 2014-07-31
- Completion
- 2015-10-31
Countries
- Canada
Study Locations
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