Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stent | Placebo Comparator | Stent Implantation (DES or BMS), no further treatment |
|
| DCB | Active Comparator | "DEBonly" strategy: treatment with drug coated balloon, additional spot-stenting in case of severe dissection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stent | Device | bare metal stent implantation, any bare metal stent is allowed from different companies |
|
| Measure | Description | Time Frame |
|---|---|---|
| MACE | MACE means the occurence of cardiac death, reinfarction, or target lesion revascularization | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Stent thrombosis (ARC | 9 months, 3 years, 5 years | |
| Mortality (cardiac and non-cardiac) | 9 months, 3 years, 5 years | |
| Reinfarction |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bruno Scheller, MD | Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes | Homburg/Saar | Saarland | 66421 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31659986 | Derived | Scheller B, Ohlow MA, Ewen S, Kische S, Rudolph TK, Clever YP, Wagner A, Richter S, El-Garhy M, Bohm M, Degenhardt R, Mahfoud F, Lauer B. Bare metal or drug-eluting stent versus drug-coated balloon in non-ST-elevation myocardial infarction: the randomised PEPCAD NSTEMI trial. EuroIntervention. 2020 Apr 17;15(17):1527-1533. doi: 10.4244/EIJ-D-19-00723. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015607 | Stents |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| SeQuent(R) Please coated balloon | Combination Product | Angioplasty with Drug coated balloon (DCB) |
|
|
| 9 months, 3 years, 5 years |
| target lesion revascularization | 9 months, 3 years, 5 years |
| target vessel revascularization | 9 months, 3 years, 5 years |
| any revascularization | 9 months, 3 years, 5 years |
| D009203 |
| Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |