Multi-Center Clinical Trial: Evaluation of Effectiveness... | NCT00415961

Studies
Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety

NCT00415961

Sponsor

Conor Medsystems

Status

Terminated

Last Update Posted

Jan 9, 2009Estimated

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Coronary Disease

Interventions

CoStar Paclitaxel Drug-Eluting Coronary Stent System

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Not provided

Completion Date

May 2012Estimated

First Submitted Date

Dec 22, 2006

First Submission Date that Met QC Criteria

Dec 22, 2006

First Posted Date

Dec 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2009

Last Update Posted Date

Jan 9, 2009Estimated

Name	Class
Getz Pharma	INDUSTRY

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	CoStar Paclitaxel drug eluting stent	Device: CoStar Paclitaxel Drug-Eluting Coronary Stent System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CoStar Paclitaxel Drug-Eluting Coronary Stent System	Device	CoStar Paclitaxel Drug-Eluting Coronary Stent System	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
In-segment late lumen loss at 9 months, as measured by QCA.		9 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shigeru Saito, MD	ShonanKamakura General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shonan Kamakura General Hospital		Kamakura		247-8533	Japan

Condition Browse Module

MeSH Terms

ID	Term
D003327	Coronary Disease

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided