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| Name | Class |
|---|---|
| EvidentIQ Germany GmbH | UNKNOWN |
| Abbott | INDUSTRY |
| Technical University of Munich | OTHER |
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The hypothesis of the study is, that there is a significant interaction in treatment effect between the OCT pattern of neointima (heterogeneous or homogeneous) and the type of percutaneous coronary intervention (drug-eluting stent or drug-coated balloon) in patients with in-stent restenosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| homogenous | Other | Stratification - homogenous pattern |
|
| heterogenous | Other | Stratification - homogenous pattern |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug eluting stent (DES) | Device | DES-implantation with an everolimus-eluting stent (Xience, Abbott Vascular) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint of major adverse cardiac event (MACE) | Composite endpoint of major adverse cardiac event (MACE)
| 24 months of clinical follow-up after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Target lesion failure (TLF): a composite of cardiac death, target-vessel myocardial infarction and TLR | 24 months of clinical follow-up after randomization | |
| Individual endpoints of the composite endpoints |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Felix Voll, MD | Contact | +49 89 1218 2749 | voll@dhm.mhn.de | |
| Salvatore Cassese, MD, PHD | Contact | +49 89 1218 2764 | cassese@dhm.mhn.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Frankfurt | Recruiting | Frankfurt am Main | Hesse | D-60596 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40588613 | Derived | Simonetti F, Voll F, Alfonso F, Grasser C, Janisch M, Joner M, Kessler T, Kuna C, Leistner DM, Lenz T, Presch A, Rheude T, Sager H, Schunkert H, Starnecker F, Wiebe J, Kastrati A, Cassese S, Xhepa E. Intracoronary Stenting and Restenosis - Randomized Trial of Drug-Eluting Stent Implantation or Drug-Coated Balloon Angioplasty According to Neointima Morphology in Drug-Eluting Stent REstenosis 5: Rationale and Design of the ISAR-DESIRE 5 Trial. J Cardiovasc Transl Res. 2025 Oct;18(5):1176-1184. doi: 10.1007/s12265-025-10650-x. Epub 2025 Jun 30. |
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| Drug coated ballloon (DCB) | Device | DCB angioplasty with any commercially available drug-coated balloon |
|
| 24 months of clinical follow-up after randomization |
| Stent thrombosis according to the ARC criteria | 24 months of clinical follow-up after randomization |
| Safety endpoint: a composite endpoint of all-cause death and myocardial infarction | 24 months of clinical follow-up after randomization |
| Elisabeth-Krankenhaus Essen GmbH | Recruiting | Essen | 45138 | Germany |
|
| Universitätsklinikum Hamburg-Eppendorf | Recruiting | Hamburg | D-20246 | Germany |
|
| Deutsches Herzzentrum München | Recruiting | Munich | 80636 | Germany |
|
| Hospital Universitario de La Princesa Madrid | Recruiting | Madrid | Madrid | 28006 | Spain |
|
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D023903 | Coronary Restenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D023921 | Coronary Stenosis |
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| ID | Term |
|---|---|
| D054855 | Drug-Eluting Stents |
| ID | Term |
|---|---|
| D015607 | Stents |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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