Bare Metal Stent Versus Drug Coated Balloon With Provisional Stenting in Non-ST-Elevation Myocardial Infarction

University Hospital, Saarland210 enrolled

Overview

The aim of the present trial is to assess the efficacy of the standalone use of SeQuent(R) Please coated balloon compared to a bare metal stent (BMS) in patients with NSTEMI.

The aim of the present trial is to assess the efficacy of the standalone use of SeQuent(R) Please coated balloon compared to a bare metal stent (BMS) in patients with NSTEMI. Primary efficacy endpoint will be MACE (cardiac mortality, reinfarction, and target lesion revascularization) after 9 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

210

Conditions

Coronary Heart Disease NSTEMI

Interventions

StentDEVICE

bare metal stent implantation, any bare metal stent is allowed from different companies

SeQuent(R) Please coated balloonCOMBINATION_PRODUCT

Angioplasty with Drug coated balloon (DCB)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * NSTEMI with * Ischemic symptoms (angina pectoris) \> 30 minutes * Last symptoms within 72 hours before randomization * Positive cardiac troponin T, I, or hs-Troponin above 99th percentile * age \> 18 years * Identifiable culprit lesion without angiographic evidence of large thrombus with intended early PCI (treatment of up to two lesions allowed) Exclusion Criteria: * Cardiogenic shock * ST-elevation myocardial infarction * No identifiable culprit lesion, Indication for acute bypass surgery * Comorbidity with limited life expectancy \< 9-12 months * Contraindication for treatment with heparin, ASA and thienopyridines

Locations (1)

Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes

Homburg/Saar, Saarland, Germany

Outcomes

Primary Outcomes

MACE

MACE means the occurence of cardiac death, reinfarction, or target lesion revascularization

Time frame: 9 months