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

Aesculap

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Device: Coroflex Please (DES)

Device: Coroflex Blue (BMS) followed by SeQuent Please (DEB)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01166711

SEQUENT 1000

Details and patient eligibility

About

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.

Enrollment

202 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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