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

This study has been terminated.
Sponsor:
Information provided by:
Conor Medsystems
ClinicalTrials.gov Identifier:
NCT00440674
First received: February 23, 2007
Last updated: October 29, 2009
Last verified: October 2009

February 23, 2007
October 29, 2009
February 2007
June 2007   (final data collection date for primary outcome measure)
Adjudicated MACE at 30 days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Adjudicated MACE at 30 days
Complete list of historical versions of study NCT00440674 on ClinicalTrials.gov Archive Site
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 [ Time Frame: 8, 9, 12, 24 mos post-proc ] [ Designated as safety issue: Yes ]
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
Not Provided
Not Provided
 
Prospective, Multi-Center, Random. Study of CoStar Paclitaxel-Eluting Coronary Stent(Direct Stenting vs. Pre-Dilatation)
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
Device: CoStar Paclitaxel-eluting coronary stent system
  • Experimental: 1
    Direct stenting technique
    Intervention: Device: CoStar Paclitaxel-eluting coronary stent system
  • Experimental: 2
    Conventional stenting with pre-dilatation strategy
    Intervention: Device: CoStar Paclitaxel-eluting coronary stent system
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
18
July 2009
June 2007   (final data collection date for primary outcome measure)

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)
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00440674
The DECIDE Trial: CP-05
No
Joachim Schofer, Principal Investigator, Universitäres Herz-und Gefäßzentrum Hamburg
Conor Medsystems
Not Provided
Principal Investigator: Joachim Schofer Universitäres Herz-und Gefäßzentrum Hamburg
Conor Medsystems
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP