Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety

Coronary Disease Clinical Trial

Official title:

Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00415961
• Other study ID #: CI-CMS-005
• Status: Terminated
• Phase: N/A
• First received: December 22, 2006
• Last updated: January 8, 2009
• Start date: November 2006
• Est. completion date: May 2012

Study information

• Verified date: January 2009
• Source: Conor Medsystems
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 95 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

Device:
• CoStar Paclitaxel Drug-Eluting Coronary Stent System
CoStar Paclitaxel Drug-Eluting Coronary Stent System

Locations

Country	Name	City	State
Japan	Shonan Kamakura General Hospital	Kamakura City

Sponsors (2)

Lead Sponsor	Collaborator
Conor Medsystems	Getz Pharma

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-segment late lumen loss at 9 months, as measured by QCA.		9 months	No
Secondary	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	Yes