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Completed

NCT Number: NCT01489449

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

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.

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia NSTEMI Necrosis Non-ST Elevated Myocardial Infarction Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes

Homburg/Saar, Saarland, 66421, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

stent

Device

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

SeQuent(R) Please coated balloon

Combination Product

Angioplasty with Drug coated balloon (DCB)

Other names: SeQuent(R) Please

Primary outcomes

  1. MACE

    Time frame: 9 months

    MACE means the occurence of cardiac death, reinfarction, or target lesion revascularization

Secondary outcomes

  1. Stent thrombosis (ARC

    Time frame: 9 months, 3 years, 5 years

  2. Mortality (cardiac and non-cardiac)

    Time frame: 9 months, 3 years, 5 years

  3. Reinfarction

    Time frame: 9 months, 3 years, 5 years

  4. target lesion revascularization

    Time frame: 9 months, 3 years, 5 years

  5. target vessel revascularization

    Time frame: 9 months, 3 years, 5 years

  6. any revascularization

    Time frame: 9 months, 3 years, 5 years

Sponsors and collaborators

Lead sponsor

University Hospital, Saarland

Other

Registry information

Acronym: PEPCADNSTEMI

Important dates

Study start
2012
Primary completion
2018
Study completion
2022
First posted
Dec 9, 2011
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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