Treatment of Coronary Artery Disease (CAD) With Bare Metal Stent (BMS) Followed by Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Eluting Stent

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Coroflex Blue (BMS) followed by SeQuent Please (DEB); Device: Coroflex Please (DES)

• Registration Number: NCT01166711
• Lead Sponsor: Aesculap AG

Brief Summary

The purpose of this study is to compare the one-time application of Paclitaxel from SeQuent Please (Paclitaxel-coated Balloon Catheter) after using the Coroflex Blue (Cobalt Chromium Stent) with the slow releasing of small dose of Paclitaxel from the Coroflex Please (Paclitaxel-Eluting Stent) stent system in a non-inferiority trial.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-20
• Study First Submitted QC: 2010-07-20
• Study First Posted: 2010-07-21
• Study Start: 2010-08
• Primary Completion: 2013-02
• Study Completion: 2015-07
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-09
• Last Update Posted: 2018-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

• Symptomatic coronary artery disease including patients with chronic stable angina, unstable angina and silent ischemia
• Presence of one or more coronary artery stenosis >50% in a native coronary artery from 2.25 to 3.5 mm in diameter that can be covered with one stent
• One lesion treated with the study device

Exclusion Criteria

• Pregnancy
• Known intolerance to aspirin, clopidogrel, heparin, stainless steel, paclitaxel, cobalt, chromium or contrast material
• Inability to provide informed consent
• Currently participating in another trial before reaching the primary endpoint
• Elective surgery within 12 months of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the peri-surgical period
• Acute or recent myocardial infarction
• left ventricular ejection fraction (LVEF) < 30 %
• Stroke or transient ischemic attack within 6 months
• Stented segment longer than 23 mm
• Vessel diameter of less than 2,5 mm
• Significant calcification, chronic total occlusion (CTO) or thrombus in the target lesion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bare Metal Stent (BMS) followed by Drug Eluting Balloon (DEB)	Coroflex Blue (BMS) followed by SeQuent Please (DEB)	-
Drug Eluting Stent (DES)	Coroflex Please (DES)	-

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac events (MACE) - target vessel failure (TVF)	9 months	consisting of the composite of cardiac death, myocardial infarction (Q-wave and Non-Q wave) localized at the territory supplied by the treated vessel or target vessel revascularization (TVR) by either percutaneous coronary intervention or bypass graft surgery in the overall population

Secondary Outcome Measures

Name	Time	Method
Angiographic and clinical stent thrombosis	3 years
In-stent and in-segment minimal luminal diameter (MLD)	9 months
In-segment percent diameter stenosis (%DS)	9 months
In-stent and in-segment late luminal loss	9 months
Major adverse cardiac events (MACE)	1 year	defined as the composite of cardiovascular death, stroke, myocardial infarction (MI) or ischemia-driven target lesion revascularization (TLR), as well as the individual components of target vessel revascularization (TVR) and Major adverse cardiac events (MACE) and stent thrombosis
in-stent binary restenosis	9 months	defined as \>= 50 % diameter stenosis (% DS)

Trial Locations

Locations (1)

Upper Silesian Heart Center; 🇵🇱 Katowice, Poland