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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Heart Disease, NSTEMI

Intervention / Treatment
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* Device: Stent
* Combination Product: SeQuent(R) Please coated balloon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Stent<br>Stent Implantation (DES or BMS), no further treatment | Device: Stent<br>* bare metal stent implantation, any bare metal stent is allowed from different companies<br>|
| Active Comparator: DCB<br>DEBonly strategy: treatment with drug coated balloon, additional spot-stenting in case of severe dissection | Combination Product: SeQuent(R) Please coated balloon<br>* Angioplasty with Drug coated balloon (DCB)<br>* Other names: SeQuent(R) Please;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE | MACE means the occurence of cardiac death, reinfarction, or target lesion revascularization | 9 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug coated balloon, NSTEMI