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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01489449

Acronym

PEPCADNSTEMI

Enrollment

210

Registered

2011-12-09

Start date

2012-12-31

Completion date

2022-06-23

Last updated

2023-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease, NSTEMI

Keywords

drug coated balloon, NSTEMI

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.

Interventions

DEVICEStent

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

COMBINATION_PRODUCTSeQuent(R) Please coated balloon

Angioplasty with Drug coated balloon (DCB)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
MACE	9 months	MACE means the occurence of cardiac death, reinfarction, or target lesion revascularization

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026