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

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ClinicalTrials.gov Identifier: NCT00440674
Recruitment Status : Terminated
First Posted : February 27, 2007
Last Update Posted : October 30, 2009
Sponsor:
Information provided by:
Conor Medsystems

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: CoStar Paclitaxel-eluting coronary stent system Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2007
Actual Primary Completion Date : June 2007
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms
Drug Information available for: Paclitaxel
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Direct stenting technique
 Device: CoStar Paclitaxel-eluting coronary stent system
Experimental: 2
Conventional stenting with pre-dilatation strategy
 Device: CoStar Paclitaxel-eluting coronary stent system


Outcome Measures
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Primary Outcome Measures :
  1. Adjudicated MACE at 30 days [ Time Frame: 30 days ]

Secondary Outcome Measures :
  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 [ Time Frame: 8, 9, 12, 24 mos post-proc ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00440674


Locations
Germany
Universitäres Herz-und Gefäßzentrum Hamburg
Hamburg, Germany, D-22527
Sponsors and Collaborators
Conor Medsystems
Investigators
Principal Investigator: Joachim Schofer Universitäres Herz-und Gefäßzentrum Hamburg
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Joachim Schofer, Principal Investigator, Universitäres Herz-und Gefäßzentrum Hamburg
ClinicalTrials.gov Identifier: NCT00440674     History of Changes
Other Study ID Numbers: The DECIDE Trial: CP-05
First Posted: February 27, 2007    Key Record Dates
Last Update Posted: October 30, 2009
Last Verified: October 2009

Keywords provided by Conor Medsystems:
Direct Stenting
Angioplasty
Pre-dilatation
Drug-eluting stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Aneurysm
Dilatation, Pathologic
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
 Pathological Conditions, Anatomical
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action