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 :
Active, not recruiting
First Posted : December 9, 2011
Last Update Posted : November 4, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Heart Disease NSTEMI | Device: Stent Device: SeQuent(R) Please coated balloon | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 210 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Bare Metal Stent Versus Drug Coated Balloon With Provisional Stenting in Non-ST-Elevation Myocardial Infarction |
Actual Study Start Date : | December 2012 |
Actual Primary Completion Date : | June 23, 2018 |
Estimated Study Completion Date : | June 23, 2022 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Stent
Stent Implantation (DES or BMS), no further treatment
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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
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Device: SeQuent(R) Please coated balloon
Angioplasty with Drug coated balloon (DCB)
Other Name: SeQuent(R) Please |
- MACE [ Time Frame: 9 months ]MACE means the occurence of cardiac death, reinfarction, or target lesion revascularization
- Stent thrombosis (ARC [ Time Frame: 9 months, 3 years, 5 years ]
- Mortality (cardiac and non-cardiac) [ Time Frame: 9 months, 3 years, 5 years ]
- Reinfarction [ Time Frame: 9 months, 3 years, 5 years ]
- target lesion revascularization [ Time Frame: 9 months, 3 years, 5 years ]
- target vessel revascularization [ Time Frame: 9 months, 3 years, 5 years ]
- any revascularization [ Time Frame: 9 months, 3 years, 5 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Germany | |
Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes | |
Homburg/Saar, Saarland, Germany, 66421 |
Principal Investigator: | Bruno Scheller, MD | Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes |
Responsible Party: | University Hospital, Saarland |
ClinicalTrials.gov Identifier: | NCT01489449 |
Other Study ID Numbers: |
PEPCAD NSTEMI |
First Posted: | December 9, 2011 Key Record Dates |
Last Update Posted: | November 4, 2020 |
Last Verified: | October 2020 |
drug coated balloon NSTEMI |
Myocardial Infarction Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia Non-ST Elevated Myocardial Infarction Infarction |
Ischemia Pathologic Processes Necrosis Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases |