Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE ABT-578 Eluting Driver Coronary Stent in De Novo Native Coronary Artery Lesions

Medtronic Vascular1 site in 1 country1,200 target enrollmentJune 2003

ConditionsCoronary Artery Disease Arterial Occlusive Diseases Coronary Disease Coronary Arteriosclerosis Heart Diseases Myocardial Ischemia Vascular Diseases Ischemia Arteriosclerosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Medtronic Vascular
Enrollment: 1200
Locations: 1
Primary Endpoint: Target Vessel Failure Rate at 9 months post procedure
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To demonstrate the safety and efficacy of the Driver Coronary Stent coated with 10 mcg/mm ABT-578 compared to the uncoated Driver Stent for the treatment of single de novo lesions in native coronary arteries 2.25-3.5 mm in diameter.

Registry

clinicaltrials.gov

Start Date

June 2003

End Date

July 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic Vascular

Eligibility Criteria

Inclusion Criteria

•Subject is an acceptable candidate for PTCA, stenting, and emergent CABG.
•Subject must have clinical evidence of ischemic heart disease or a positive functional study.
•Subject has single vessel disease or has multivessel disease with only moderate stenosis (max 50-60% or total occlusion (100%) for which no interventions are planned at the time of study inclusion).
•Target lesion / vessel must meet the following criteria:
•Target lesion is a single de novo lesion that has not been previously treated with any interventional procedure. Only one lesion may be treated per subject
•Target vessel must be a native coronary artery with a stenosis of \>=50% and \<100%
•Target lesion must be \>= 14 mm and ≤ 27 mm in length
•Target vessel reference diameter must be \>= 2.25 mm and ≤3.5 mm
•Female subjects of childbearing potential must have a negative pregnancy test within 7 days before the procedure.
•Subject or subject's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site

Exclusion Criteria

•A documented left ventricular ejection fraction \<30%
•A known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, cobalt, nickel, chromium, or a sensitivity to contrast media, which cannot be adequately pre-medicated
•History of an allergic reaction or significant sensitivity or receiving drugs similar to/or synergistic to ABT-578 (rapamycin, tacrolimus, sirolimus, CCI-779 or other analogues).
•A platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³, or a WBC \<3,000 cells/mm³
•Evidence of an acute myocardial infarction within 72 hours of the intended treatment (defined as: Q wave or non-Q wave infarction having CK enzymes \>2X the upper laboratory normal with the presence of a CK-MB elevated above the Institution's upper limit of normal).
•Creatinine \>2.0 mg/dl
•A previous coronary interventional procedure of any kind within the 30 days prior to the procedure
•Subject requires planned interventional treatment of either the target or any non-target vessel within 30 days post-procedure
•Target lesion requires treatment with a device other than PTCA prior to stent placement
•Previous stenting anywhere in the target vessel

Outcomes

Primary Outcomes

Target Vessel Failure Rate at 9 months post procedure

Time Frame: 9 months

Secondary Outcomes

Device Success Lesion Success Procedure Success Major Cardiac Adverse Events (MACE) at 30 days and 6, 9, and 12 months, and annually thereafter out to 5 years. Late loss at 8 months as measured by QCA(30 days and 6, 9, and 12 months, and annually thereafter out to 5 years.)