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 2016 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: May 11, 2016
Last verified: May 2016
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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: 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 2019 |
| Estimated Primary Completion Date: | September 2017 (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 (Adult, Senior) |
| 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
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
| 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 11, 2016 |
| Health Authority: | Germany: Ministry of Health |
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 Ischemia |
Pathologic Processes Necrosis Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases |
ClinicalTrials.gov processed this record on September 28, 2016