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

University Hospital, Saarland

Status and phase: Completed; Phase 4

Conditions: Coronary Heart Disease; NSTEMI

Treatments: Device: Stent; Combination Product: SeQuent(R) Please coated balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT01489449

PEPCAD NSTEMI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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210 participants in 2 patient groups, including a placebo group

Stent

Placebo Comparator group

Description:

Stent Implantation (DES or BMS), no further treatment

Treatment:

Device: Stent

DCB

Active Comparator group

Description:

"DEBonly" strategy: treatment with drug coated balloon, additional spot-stenting in case of severe dissection

Treatment:

Combination Product: SeQuent(R) Please coated balloon