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

NCT00440674 | Terminated Phase 4

• 1 other identifier: The DECIDE Trial: CP-05
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Direct Stenting; Angioplasty; Pre-dilatation; Drug-eluting stent

Outcome Measures

Primary Outcomes (1)

• Adjudicated MACE at 30 days

  30 days

Secondary Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

Direct stenting technique

Device: CoStar Paclitaxel-eluting coronary stent system

2

EXPERIMENTAL

Conventional stenting with pre-dilatation strategy

Device: CoStar Paclitaxel-eluting coronary stent system

Interventions

CoStar Paclitaxel-eluting coronary stent system DEVICE

1; 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Conor Medsystems: lead

Study Sites (1)

Universitäres Herz-und Gefäßzentrum Hamburg

Hamburg, Hamburg, D-22527, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Joachim Schofer

  Universitäres Herz-und Gefäßzentrum Hamburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 23, 2007
• First Posted: February 27, 2007
• Study Start: February 1, 2007
• Primary Completion: June 1, 2007
• Study Completion: July 1, 2009
• Last Updated: October 30, 2009

Record last verified: 2009-10

Locations

DE (1)