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Clinical Trials/NCT01489449
NCT01489449
Completed
Phase 4

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

University Hospital, Saarland1 site in 1 country210 target enrollmentDecember 2012
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ConditionsCoronary Heart DiseaseNSTEMI

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Coronary Heart Disease
Sponsor
University Hospital, Saarland
Enrollment
210
Locations
1
Primary Endpoint
MACE
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2012
End Date
June 23, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Saarland
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

MACE

Time Frame: 9 months

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

Secondary Outcomes

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

Study Sites (1)

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