NCT00415961

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 27, 2006

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

January 9, 2009

Status Verified

January 1, 2009

First QC Date

December 22, 2006

Last Update Submit

January 8, 2009

Conditions

Coronary Disease

Keywords

Percutaneous Coronary Intervention (PCI)Drug-eluting stent (DES)

Outcome Measures

Primary Outcomes (1)

  • In-segment late lumen loss at 9 months, as measured by QCA.

    9 months

Secondary Outcomes (1)

  • 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

    MACE at 30 days and 8 months, Angiographic restenosis at 9 months; Clinically driven Target Lesion Revascularization at 8 months

Study Arms (1)

1

EXPERIMENTAL

CoStar Paclitaxel drug eluting stent

Device: CoStar Paclitaxel Drug-Eluting Coronary Stent System

Interventions

CoStar Paclitaxel Drug-Eluting Coronary Stent SystemDEVICE

CoStar Paclitaxel Drug-Eluting Coronary Stent System

1

Eligibility Criteria

Age20 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shonan Kamakura General Hospital

Kamakura, 247-8533, Japan

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Shigeru Saito, MD

    ShonanKamakura General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 22, 2006

First Posted

December 27, 2006

Study Start

November 1, 2006

Study Completion

May 1, 2012

Last Updated

January 9, 2009

Record last verified: 2009-01

Locations

JP(1)