Prospective, Multi-Center, Random. Study of CoStar Paclitaxel-Eluting Coronary Stent(Direct Stenting vs. Pre-Dilatation)

Study 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.

Official Title
-----------------
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

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: CoStar Paclitaxel-eluting coronary stent system


Participation Criteria
=================
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 Patient is currently, or has been treated with Paclitaxel (systemic) within12 months of the index procedure Comorbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study Left main coronary artery disease (stenosis >50%), whether protected or unprotected. Target lesion involves a bifurcation with a diseased (>50% stenotic) branch vessel >2.0 mm in diameter that requires intervention. Target lesion is totally occluded Thrombolysis In MI (TIMI flow ≤1). The target vessel has had prior drug-eluting stent placement to vessel segment (or branch) proximal to intended target lesion site. Angiographic restenosis of any segment of the target vessel that has undergone prior PCI. Angiographic evidence of atherosclerotic disease with >50% diameter stenosis (by visual estimate) proximal or distal to the target lesion (applies to the major epicardial portion of the target vessel and contiguous vessel segment if the target lesion is located in a branch vessel)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Direct stenting technique | Device: CoStar Paclitaxel-eluting coronary stent system<br> <br> |
| Experimental: 2<br>Conventional stenting with pre-dilatation strategy | Device: CoStar Paclitaxel-eluting coronary stent system<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjudicated MACE at 30 days |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Direct Stenting, Angioplasty, Pre-dilatation, Drug-eluting stent