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Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety

This study has been terminated.
Sponsor:
Collaborator:
Getz Pharma
Information provided by:
Conor Medsystems
ClinicalTrials.gov Identifier:
NCT00415961
First received: December 22, 2006
Last updated: January 8, 2009
Last verified: January 2009
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

Drug Information available for: Paclitaxel
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   20 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00415961

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

No publications provided

Responsible Party: Shigeru Saito, MD, ShonanKamakura General Hospital
ClinicalTrials.gov Identifier: NCT00415961     History of Changes
Other Study ID Numbers: CI-CMS-005
Study First Received: December 22, 2006
Last Updated: January 8, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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
Arteriosclerosis
Arterial Occlusive Diseases
Paclitaxel
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013