Bare Metal Stent Versus Drug Coated Balloon With Provisional Stenting in Non-ST-Elevation Myocardial Infarction (PEPCADNSTEMI)
This study is not yet open for participant recruitment.
Verified December 2011 by University Hospital, Saarland
Sponsor:
University Hospital, Saarland
Information provided by (Responsible Party):
University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT01489449
First received: November 27, 2011
Last updated: December 9, 2011
Last verified: December 2011
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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: bare metal stent (BMS) 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 2011 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: BMS
Bare Metal Stent implantation, no further treatment
|
Device: bare metal stent (BMS)
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
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 | Not yet 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: | December 9, 2011 |
| 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 May 23, 2013