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

Primary Purpose

Coronary Heart Disease, NSTEMI

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Stent
SeQuent(R) Please coated balloon
Sponsored by
University Hospital, Saarland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring drug coated balloon, NSTEMI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Stent

DCB

Arm Description

Stent Implantation (DES or BMS), no further treatment

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Stent thrombosis (ARC
Mortality (cardiac and non-cardiac)
Reinfarction
target lesion revascularization
target vessel revascularization
any revascularization

Full Information

First Posted
November 27, 2011
Last Updated
May 2, 2023
Sponsor
University Hospital, Saarland
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1. Study Identification

Unique Protocol Identification Number
NCT01489449
Brief Title
Bare Metal Stent Versus Drug Coated Balloon With Provisional Stenting in Non-ST-Elevation Myocardial Infarction
Acronym
PEPCADNSTEMI
Official Title
Bare Metal Stent Versus Drug Coated Balloon With Provisional Stenting in Non-ST-Elevation Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 2012 (Actual)
Primary Completion Date
June 23, 2018 (Actual)
Study Completion Date
June 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Saarland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, NSTEMI
Keywords
drug coated balloon, NSTEMI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stent
Arm Type
Placebo Comparator
Arm Description
Stent Implantation (DES or BMS), no further treatment
Arm Title
DCB
Arm Type
Active Comparator
Arm Description
"DEBonly" strategy: treatment with drug coated balloon, additional spot-stenting in case of severe dissection
Intervention Type
Device
Intervention Name(s)
Stent
Intervention Description
bare metal stent implantation, any bare metal stent is allowed from different companies
Intervention Type
Combination Product
Intervention Name(s)
SeQuent(R) Please coated balloon
Other Intervention Name(s)
SeQuent(R) Please
Intervention Description
Angioplasty with Drug coated balloon (DCB)
Primary Outcome Measure Information:
Title
MACE
Description
MACE means the occurence of cardiac death, reinfarction, or target lesion revascularization
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Stent thrombosis (ARC
Time Frame
9 months, 3 years, 5 years
Title
Mortality (cardiac and non-cardiac)
Time Frame
9 months, 3 years, 5 years
Title
Reinfarction
Time Frame
9 months, 3 years, 5 years
Title
target lesion revascularization
Time Frame
9 months, 3 years, 5 years
Title
target vessel revascularization
Time Frame
9 months, 3 years, 5 years
Title
any revascularization
Time Frame
9 months, 3 years, 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Scheller, MD
Organizational Affiliation
Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes
City
Homburg/Saar
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany

12. IPD Sharing Statement

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

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