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

Coronary Artery Disease Clinical Trial

— DECIDE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00440674
• Other study ID #: The DECIDE Trial: CP-05
• Status: Terminated
• Phase: Phase 4
• First received: February 23, 2007
• Last updated: October 29, 2009
• Start date: February 2007
• Est. completion date: July 2009

Study information

• Verified date: October 2009
• Source: Conor Medsystems
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: July 2009
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• CoStar Paclitaxel-eluting coronary stent system

Locations

Country	Name	City	State
Germany	Universitäres Herz-und Gefäßzentrum Hamburg	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Conor Medsystems

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adjudicated MACE at 30 days		30 days	Yes
Secondary	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	Yes