The Efficacies of The New Paclitaxel-Eluting CoroflexTM Please Stent in Percutaneous Coronary Intervention

Phase 3

• Conditions: Coronary Artery Disease
• Interventions: Device: Coroflex Please stent implantation; Device: Taxus stent implantation

• Registration Number: NCT00699543
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Objectives

: To evaluate the clinical efficacy, angiographic outcomes, and safety of the new paclitaxel-eluting coronary stent (CoroflexTM Please, B Braun, Germany), compared with another paclitaxel-eluting coronary stent system (TaxusTM, Boston Scientific, USA) in the treatment of coronary stenosis.

Study Design

: Prospective, open label, 2: 1 randomized multi-center trial. Patients will be randomized according to the type of drug eluting stent ( CoroflexTM Please vs. TaxusTM). Randomization will also be stratified per hospital for the presence of DM and the presence of long lesions (lesion length \> 28mm)

Patient Enrollment

:915 patients enrolled at 13 centers in Korea.

Patient Follow-Up

:Clinical follow-up will occur at 1, 4, 9, 12 months and 2, 3years after intervention. Investigator or designee may conduct follow-up as telephone contacts or office visits.

Primary Endpoint

:Clinically driven Target vessel Revascularization (TVR) at 9 months.

Secondary Endpoints

:A. Clinical safety and efficacy end points

1. Major Cardiac Adverse Events (MACE; All Death, cardiac death, Myocardial infarction (Q-wave and non-Q wave), TVR)

2. Target Vessel Failure (TVF; cardiovascular death, myocardial infarction, clinically driven TVR)

3. Stent thrombosis

B. Angiographic efficacy end points

1. in-stent binary restenosis by QCA

2. in-stent and in-lesion late loss by QCA

3. in-stent and in-lesion MLD and percentage diameter stenosis by QCA immediately after the index procedure and at 9 months of follow-up

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-16
• Study First Submitted QC: 2008-06-17
• Study First Posted: 2008-06-18
• Study Start: 2008-07
• Status Verified: 2013-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2013-12-15
• Last Update Posted: 2013-12-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 915

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C	Coroflex Please stent implantation	Coroflex Please stent implantation
T	Taxus stent implantation	Taxus stent implantation

Primary Outcome Measures

Name	Time	Method
Clinically driven Target vessel Revascularization (TVR)	9 months.

Secondary Outcome Measures

Name	Time	Method
In-stent and in-lesion late loss by QCA	9 months
In-stent and in-lesion MLD and percentage diameter stenosis by QCA	Immediately after the index procedure and at 9 months
Major Cardiac Adverse Events (MACE; All Death, cardiac death, Myocardial infarction (Q-wave and non-Q wave), TVR)	1, 4, 9, 12 months and 2, 3years
Target Vessel Failure (TVF; cardiovascular death, myocardial infarction, clinically driven TVR)	1, 4, 9, 12 months and 2, 3years
Stent thrombosis	1, 4, 9, 12 months and 2, 3years
In-stent binary restenosis by QCA	9 months