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

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

Conditions

• Coronary Artery Disease

Interventions

DEVICE

Coroflex Please stent implantation

Use Coroflex Please stent in the treatment of coronary stenosis

DEVICE

Taxus stent implantation

Use Taxus stent in the treatment of coronary stenosis

Sponsors & Collaborators

• B. Braun Melsungen AG

  collaborator INDUSTRY

• Seoul National University Hospital

  lead OTHER

Principal Investigators

• Hyo-Soo Kim, MD, PhD · Seoul National University Hospital

• In-Ho Chae, MD, PhD · Seoul National University Bundang Hospital

• Seung-Ho Hur, MD, Ph · Keimyung University Dongsan Medical Center

• Tae-Jin Youn, MD, PhD · Seoul National University Bundang Hospital

• Soo-Joong Kim, MD, PhD · Kyunghee University Medical Center

• Keum-Soo Park, MD, PhD · Inha University Hospital

• Byung-Ok Kim, MD, PhD · Inje University Sang-gye Paik Hospital

• Min-Su Hyon, MD, PhD · Soon Chun Hyang University Hospital

• Sang-Wook Kim, MD, PhD · Chung-Ang University Hosptial, Chung-Ang University College of Medicine

• Jong-Seon Park, MD, PhD · Yeungnam University Hospital

• Doo-Il Kim, MD, PhD · Inje University

• Tae-Joon Cha, MD, PhD · Kosin University Gospel Hospital

• Sang-Gon Lee, MD, PhD · Ulsan University Hospital

• Hee-Kyoung Jeon, MD, PhD · Uijeongbu St. Mary's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-07-31

Primary Completion

2013-12-31

Completion

2013-12-31