The DECIDE Trial: Prospective, Multi-center, Randomized Study to Evaluate the CoStar Paclitaxel-Eluting Coronary Stent System Using a Direct Stenting Technique Compared to Conventional Stenting With Pre-dilatation Strategy

Conor Medsystems1 site in 1 country18 target enrollmentFebruary 2007

ConditionsCoronary Artery Disease

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Conor Medsystems
Enrollment: 18
Locations: 1
Primary Endpoint: Adjudicated MACE at 30 days
Status: Terminated
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to evaluate the safety and effectiveness of a direct stenting technique compared to conventional stenting with pre-dilatation strategy using the CoStar Paclitaxel-eluting coronary stent system for the treatment of a single de novo lesion in a native coronary artery ≤ 25 mm long in a native coronary artery 2.5-3.5 mm diameter.

Detailed Description

Prospective, multi-center, randomized (1:1), open-label study to evaluate direct stenting compared to conventional stenting with pre-dilatation strategy in treatment of a single de novo Lesion of a single native coronary artery in patients undergoing elective percutaneous coronary intervention.

Registry

clinicaltrials.gov

Start Date

February 2007

End Date

July 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Conor Medsystems

Eligibility Criteria

Inclusion Criteria

•Eligible for percutaneous coronary intervention
•Documented stable or unstable angina pectoris or with documented ischemia, or with documented silent ischemia
•Left ventricular ejection fraction (LVEF) ≥25% documented within the last 6 weeks
•Acceptable candidate for coronary artery bypass graft surgery
•Single target vessel / single target lesion to be treated
•Target lesion may be composed of multiple lesions but must be completely coverable by one (1) study stent
•Cumulative target lesion length per vessel is ≤ 25 mm
•RVD of 2.5-3.5 mm
•Target lesion diameter stenosis ≥ 50% and \< 100%
•Target vessel has not undergone prior revascularization within the preceding 6 months

Exclusion Criteria

•Known sensitivity to cobalt chromium, Paclitaxel or PLGA
•Acute MI within 72 hours prior to the index procedure as defined by the presence of a new pathologic Q-wave, or a creatine kinase (CK) level of \> 2x the laboratory upper limits of normal and elevated MB
•The patient is in cardiogenic shock
•Cerebrovascular Accident (CVA) within the past 6 months
•Acute or chronic renal dysfunction (creatinine \> 2.0 mg/dL or \> 150 µmol/L)/
•Contraindication to ASA or to Clopidogrel
•Thrombocytopenia (platelet count \<100,000/mm3)
•Active gastrointestinal (GI) bleeding within the past three months
•Any prior true anaphylactic reaction to contrast agents
•Patient is currently taking Colchicine

Outcomes

Primary Outcomes

Adjudicated MACE at 30 days

Time Frame: 30 days

Secondary Outcomes

Primary & second. device success, Lesion and Procedure success, Adjudicated MACE 8, 9, 12, 24 mos post-proc; Binary restenosis, MLD, Clin. driven TLR 8 mos post-proc; Clinic. driven TVR 8 mos post-proc; Overall TVR/TLR 8 mos post-proc; Stent thrombosis(8, 9, 12, 24 mos post-proc)