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

Coronary Artery Disease Clinical Trial

Official title:
The Efficacies of The New Paclitaxel-Eluting CoroflexTM Please Stent in Percutaneous Coronary Intervention: Comparison or Efficacy Between COroflex PLEASe ANd TaxusTM Stent

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00699543
Study type Interventional
Source Seoul National University Hospital
Contact
Status Active, not recruiting
Phase Phase 3
Start date July 2008
Completion date December 2013
View Details
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