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

May 2, 2023 updated by: University Hospital, Saarland
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saarland
      • Homburg/Saar, Saarland, Germany, 66421
        • Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Saarland

Investigators

  • Principal Investigator: Bruno Scheller, MD, Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2012

Primary Completion (Actual)

June 23, 2018

Study Completion (Actual)

June 23, 2022

Study Registration Dates

First Submitted

November 27, 2011

First Submitted That Met QC Criteria

December 7, 2011

First Posted (Estimate)

December 9, 2011

Study Record Updates

Last Update Posted (Estimate)

May 4, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEPCAD NSTEMI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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