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Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety

This study has been terminated.
Getz Pharma
Information provided by:
Conor Medsystems Identifier:
First received: December 22, 2006
Last updated: January 8, 2009
Last verified: January 2009
This trial aims to demonstrate the non-inferiority of the CI-CMS-005 Coronary Stent System to the study device as well as to the TAXUS™ Express2™ Drug-Eluting Coronary Stent System in in-segment late lumen loss at 9 months after treatment of a single de novo lesion per vessel.

Condition Intervention
Coronary Disease
Device: CoStar Paclitaxel Drug-Eluting Coronary Stent System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety

Resource links provided by NLM:

Further study details as provided by Conor Medsystems:

Primary Outcome Measures:
  • In-segment late lumen loss at 9 months, as measured by QCA. [ Time Frame: 9 months ]

Secondary Outcome Measures:
  • Device, lesion and procedure success; MACE at 30 days and 8 months, Angiographic restenosis at 9 months; Clinically driven Target Lesion Revascularization at 8 months [ Time Frame: MACE at 30 days and 8 months, Angiographic restenosis at 9 months; Clinically driven Target Lesion Revascularization at 8 months ]

Estimated Enrollment: 120
Study Start Date: November 2006
Estimated Study Completion Date: May 2012
Arms Assigned Interventions
Experimental: 1
CoStar Paclitaxel drug eluting stent
Device: CoStar Paclitaxel Drug-Eluting Coronary Stent System
CoStar Paclitaxel Drug-Eluting Coronary Stent System

Detailed Description:
This is a complementary, multi-center, open-label, single-arm trial investigating angiographic and clinical patient outcomes in Japan. Historical data from the 2-arm randomized COSTAR II trial will be used for comparison.

Ages Eligible for Study:   20 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

General Inclusion Criteria

  • Eligible for percutaneous coronary intervention (PCI)
  • Documented stable or unstable angina pectoris (Class I, II, III or IV), documented ischemia, or documented silent ischemia
  • Documented LVEF ≥25% within the last 6 weeks.
  • Eligible for coronary artery bypass graft surgery (CABG)

Exclusion Criteria:

General Exclusion Criteria: -

  • Known sensitivity to paclitaxel or polymeric matrices.
  • Planned treatment with any other PCI device in the target vessel(s).
  • MI within 72 hours prior to the index procedure
  • 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 ticlopidine
  • Thrombocytopenia
  • Active GI bleeding within past three months
  • Known allergy to cobalt chromium
  • Any prior true anaphylactic reaction to contrast agents
  Contacts and Locations
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Please refer to this study by its identifier: NCT00415961

Shonan Kamakura General Hospital
Kamakura City, Japan, 247-8533
Sponsors and Collaborators
Conor Medsystems
Getz Pharma
Principal Investigator: Shigeru Saito, MD ShonanKamakura General Hospital
  More Information

Responsible Party: Shigeru Saito, MD, ShonanKamakura General Hospital Identifier: NCT00415961     History of Changes
Other Study ID Numbers: CI-CMS-005
Study First Received: December 22, 2006
Last Updated: January 8, 2009

Keywords provided by Conor Medsystems:
Percutaneous Coronary Intervention (PCI)
Drug-eluting stent (DES)

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017