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NCT01489449 Clinical Trial

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

Coronary Heart Disease Clinical Trial

— PEPCADNSTEMI  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01489449
Other study ID # PEPCAD NSTEMI
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 2012
Est. completion date June 23, 2022

Study information
Verified date May 2023
Source Universität des Saarlandes
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 210
Est. completion date June 23, 2022
Est. primary completion date June 23, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Stent
bare metal stent implantation, any bare metal stent is allowed from different companies
Combination Product:
• SeQuent(R) Please coated balloon
Angioplasty with Drug coated balloon (DCB)

Locations
Country Name City State
Germany Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes Homburg/Saar Saarland

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Saarland

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary MACE MACE means the occurence of cardiac death, reinfarction, or target lesion revascularization 9 months
Secondary Stent thrombosis (ARC 9 months, 3 years, 5 years
Secondary Mortality (cardiac and non-cardiac) 9 months, 3 years, 5 years
Secondary Reinfarction 9 months, 3 years, 5 years
Secondary target lesion revascularization 9 months, 3 years, 5 years
Secondary target vessel revascularization 9 months, 3 years, 5 years
Secondary any revascularization 9 months, 3 years, 5 years
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