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

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ClinicalTrials.gov Identifier: NCT01489449
Recruitment Status : Recruiting
First Posted : December 9, 2011
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Saarland

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease NSTEMI Device: Stent Device: SeQuent(R) Please coated balloon Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bare Metal Stent Versus Drug Coated Balloon With Provisional Stenting in Non-ST-Elevation Myocardial Infarction
Study Start Date : December 2012
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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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
 Device: SeQuent(R) Please coated balloon
Angioplasty with Drug coated balloon (DCB)
Other Name: SeQuent(R) Please


Outcome Measures
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Primary Outcome Measures :
  1. MACE [ Time Frame: 9 months ]
    MACE means the occurence of cardiac death, reinfarction, or target lesion revascularization


Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01489449


Contacts
Contact: Bruno Scheller, MD +49 6841 162 3351 bruno.scheller@uks.eu

Locations
Germany
Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes Recruiting
Homburg/Saar, Saarland, Germany, 66421
Contact: Bruno Scheller, MD    +49 6841 162 3351    bruno.scheller@uks.eu   
Sponsors and Collaborators
University Hospital, Saarland
Investigators
Principal Investigator: Bruno Scheller, MD Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes
More Information
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Responsible Party: University Hospital, Saarland
ClinicalTrials.gov Identifier: NCT01489449     History of Changes
Other Study ID Numbers: PEPCAD NSTEMI
First Posted: December 9, 2011    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by University Hospital, Saarland:
drug coated balloon
NSTEMI

Additional relevant MeSH terms:
Infarction
Heart Diseases
Myocardial Infarction
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Non-ST Elevated Myocardial Infarction
 Ischemia
Pathologic Processes
Necrosis
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases