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

Phase 4

Completed

• Conditions: NSTEMI; Coronary Heart Disease
• Interventions: Device: Stent; Combination Product: SeQuent(R) Please coated balloon

• Registration Number: NCT01489449
• Lead Sponsor: University Hospital, Saarland

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2011-11-27
• Study First Submitted QC: 2011-12-07
• Study First Posted: 2011-12-09
• Study Start: 2012-12
• Primary Completion: 2018-06-23
• Study Completion: 2022-06-23
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stent	Stent	Stent Implantation (DES or BMS), no further treatment
DCB	SeQuent(R) Please coated balloon	"DEBonly" strategy: treatment with drug coated balloon, additional spot-stenting in case of severe dissection

Primary Outcome Measures

Name	Time	Method
MACE	9 months	MACE means the occurence of cardiac death, reinfarction, or target lesion revascularization

Secondary Outcome Measures

Name	Time	Method
Reinfarction	9 months, 3 years, 5 years
Stent thrombosis (ARC	9 months, 3 years, 5 years
Mortality (cardiac and non-cardiac)	9 months, 3 years, 5 years
target lesion revascularization	9 months, 3 years, 5 years
any revascularization	9 months, 3 years, 5 years
target vessel revascularization	9 months, 3 years, 5 years

Trial Locations

Locations (1)

Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes; 🇩🇪 Homburg/Saar, Saarland, Germany