Reduced Anti-Platelet Therapy With Pimecrolimus Drug Elut... | NCT00322543

Studies
Reduced Anti-Platelet Therapy With Pimecrolimus Drug Eluting Stent (RAPID)

NCT00322543

Sponsor

Conor Medsystems

Status

Terminated

Last Update Posted

Oct 17, 2008Estimated

Enrollment

3Actual

Phase

Phase 3

Conditions

Coronary Disease

Interventions

Corio™ Pimecrolimus-eluting stent

Countries

Brazil

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

Sep 2008

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

May 2006

Primary Completion Date

Nov 2006Actual

Completion Date

May 2008Actual

First Submitted Date

May 4, 2006

First Submission Date that Met QC Criteria

May 4, 2006

First Posted Date

May 8, 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

Oct 16, 2008

Last Update Posted Date

Oct 17, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Non-randomized, single arm, multi-center, clinical trial evaluating the Corio™ pimecrolimus-eluting stent with reduced anti-platelet therapy in patients with de novo lesions of the native coronary arteries.

Detailed Description

The registry is designed to evaluate 6-month in-stent late lumen loss in patients receiving the Corio™ drug-eluting stent.

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Label	Type	Description	Intervention Names
Drug eluting stent	Experimental	Corio™ Pimecrolimus-eluting stent	Device: Corio™ Pimecrolimus-eluting stent

Name	Type	Description	Arm Group Labels	Other Names
Corio™ Pimecrolimus-eluting stent	Device		Drug eluting stent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Angiographic endpoint of in-stent late lumen loss at 6 months		6 months

Secondary Outcomes

Measure	Description	Time Frame
Major Adverse Cardiac Events (MACE) defined as an adjudicated composite of clinically driven target vessel revascularization, new myocardial infarction (MI) or cardiac death at 30 days, 6 months, 12 months and 2 years;		30 days, 6 months, 12 months and 2 years
Device, Lesion and Procedural Success; Coronary angiography at 6 months; IVUS measurements in IVUS cohort at 6 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
Left ventricular ejection fraction (LVEF) ≥25%
Acceptable candidate for coronary artery bypass graft surgery (CABG).
Target Lesion < 25 mm in length with RVD of 2.5 to 3.5 mm with visually estimated stenosis of >= 50 and < 100 %.

Exclusion Criteria:

General Exclusion Criteria

Known sensitivity to pimecrolimus, the polymer (PLGA) or cobalt chromium.
Planned treatment with any other PCI device in the target vessel(s).
MI within 72 hours prior to the index procedure
The patient is in cardiogenic shock.
Cerebrovascular Accident (CVA) within the past 6 months.
Acute or chronic renal dysfunction
Contraindication to ASA or to clopidogrel.
Thrombocytopenia
Active gastrointestinal (GI) bleeding within the past 3 months.
Any prior true anaphylactiod reaction to contrast agents
Patient is currently taking chronic systemic steroid therapy or systemic immunosuppressant therapy or topical pimecrolimus.
Female of childbearing potential.
Life expectancy of less than 24 months due to other medical conditions.
Co-morbid condition(s)
Currently participating in another investigational drug or device study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

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