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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University Hospital, Saarland
Sponsor:
Information provided by (Responsible Party):
University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT01489449
First received: November 27, 2011
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Coronary Heart Disease
NSTEMI
Device: Stent
Device: SeQuent(R) Please coated balloon
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bare Metal Stent Versus Drug Coated Balloon With Provisional Stenting in Non-ST-Elevation Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by University Hospital, Saarland:

Primary Outcome Measures:
  • MACE [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    MACE means the occurence of cardiac death, reinfarction, or target lesion revascularization


Secondary Outcome Measures:
  • Stent thrombosis (ARC [ Time Frame: 9 months, 3 years, 5 years ] [ Designated as safety issue: Yes ]
  • Mortality (cardiac and non-cardiac) [ Time Frame: 9 months, 3 years, 5 years ] [ Designated as safety issue: Yes ]
  • Reinfarction [ Time Frame: 9 months, 3 years, 5 years ] [ Designated as safety issue: Yes ]
  • target lesion revascularization [ Time Frame: 9 months, 3 years, 5 years ] [ Designated as safety issue: Yes ]
  • target vessel revascularization [ Time Frame: 9 months, 3 years, 5 years ] [ Designated as safety issue: Yes ]
  • any revascularization [ Time Frame: 9 months, 3 years, 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: December 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital, Saarland
ClinicalTrials.gov Identifier: NCT01489449     History of Changes
Other Study ID Numbers: PEPCAD NSTEMI
Study First Received: November 27, 2011
Last Updated: May 5, 2014
Health Authority: Germany: Ministry of Health

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

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

ClinicalTrials.gov processed this record on July 20, 2014