Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Atrium Medical Corporation |
---|---|
Information provided by: | Atrium Medical Corporation |
ClinicalTrials.gov Identifier: | NCT00689767 |
This First In Man study is a prospective, multicentre, single blind, randomized, controlled clinical trial of the CINATRA™ ISA 247 Coated Coronary Stent System as compared to the CINATRA™ Coronary Stent System. The study will enroll up to 100 evaluable patients at up to 7 sites. Clinical follow up will occur at 1 month, 6 months, and 1, 2, 3, 4 and 5 years post procedure. Repeat angiography and IVUS will be performed at the 6 month follow up time point for all subjects.
Condition | Intervention |
---|---|
Coronary Artery Disease |
Device: CINATRA™ Coronary Stent System Device: CINATRA™ ISA 247 Coated Coronary Stent System |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study |
Official Title: | COronary Native Artery First in Man Investigation of ISA 247 Elution to Prevent Restenotic Mechanisms |
Estimated Enrollment: | 100 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | February 2014 |
Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
This arm will receive the coated stent
|
Device: CINATRA™ ISA 247 Coated Coronary Stent System
Drug coated cobalt chromium stent implantation
|
B: Active Comparator
This arm will receive a bare metal stent
|
Device: CINATRA™ Coronary Stent System
Bare metal cobalt chromium stent implantation
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with de novo lesion in a native coronary artery >50% and <100% stenosis.
NOTE: Treatment of lesions in a non-target vessel is up to the investigator's discretion (max. two-vessel-disease).
ONLY a bare metal stent (no drug eluting stent) can be used for this treatment. Treatment of any non-target vessel lesions must be successfully completed before enrolling patient and placing study stent.
Exclusion Criteria:
Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
NOTE: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
Any planned interventional treatment of any vessel post study procedure.
Exclusion Criteria Related to Angiography
Belgium | |
Middelheim Hospital | Recruiting |
Antwerp, Belgium | |
Contact: Glenn Van Langenhove, MD Glenn.Vanlangenhove@zna.be |
Principal Investigator: | Glenn Van Langenhove, MD | Middelheim Hospital, Antwerp, Belgium |
Responsible Party: | Atrium Medical Corporation ( Vice President of Regulatory Affairs ) |
Study ID Numbers: | 801, Application #: 2008-001347-20 |
Study First Received: | June 2, 2008 |
Last Updated: | June 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00689767 |
Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
drug eluting stent |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Chromium Cobalt |
Myocardial Ischemia Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Cardiovascular Diseases |