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Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety

Primary Purpose

Coronary Disease

Status

Terminated

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

CoStar Paclitaxel Drug-Eluting Coronary Stent System

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring Percutaneous Coronary Intervention (PCI), Drug-eluting stent (DES)

Eligibility Criteria

20 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Shonan Kamakura General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

CoStar Paclitaxel drug eluting stent

Outcomes

Primary Outcome Measures

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

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

Full Information

NCT ID

NCT00415961

First Posted

December 22, 2006

Last Updated

January 8, 2009

Sponsor

Conor Medsystems

Collaborators

Getz Pharma

1. Study Identification

Unique Protocol Identification Number

NCT00415961

Brief Title

Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety

Official Title

Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Terminated

Study Start Date

November 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

May 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Conor Medsystems

Collaborators

Getz Pharma

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

CoStar Paclitaxel drug eluting stent

Intervention Type

Device

Intervention Name(s)

CoStar Paclitaxel Drug-Eluting Coronary Stent System

Intervention Description

CoStar Paclitaxel Drug-Eluting Coronary Stent System

Primary Outcome Measure Information:

Title

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

Time Frame

9 months

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shigeru Saito, MD

Organizational Affiliation

ShonanKamakura General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shonan Kamakura General Hospital

City

Kamakura City

ZIP/Postal Code

247-8533

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety

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