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The 001 DIOR study is a prospective, multicenter registry of percutaneous coronary intervention (PCI) to assess the clinical success, efficacy and safety of the Paclitaxel-eluting balloon DIOR (Eurocor GmbH, Germany) for the treatment of de novo ostial bifurcated lesions (001 of Medina classification). The DIOR balloon will be used to treat the stenotic site branch.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dior | Other | One arm observational registry using the Dior paclitaxel eluting balloon for the treatment of de novo ostial bifurcated lesions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DIOR drug-eluting PTCA balloon | Device | Treatment for 45 seconds with the DIOR balloon (3 µg/mm2 Paclitaxel concentration on balloon surface) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events (MACE) | MACE rate defined as the rate of cardiac death and/or myocardial infarction (MI) and/or target lesion revascularization (TLR) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| target vessel revascularization (TVR) rate, either symptom or ischemia-driven | 6 months | |
| Segment treated thrombosis (STT), according to ARC definitions | 6 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Serra, MD, PhD | Hospital Sant Pau, Barcelona | Principal Investigator |
| Beatriz Vaquerizo, MD, PhD | Hospital Sant Pau, Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Mar | Barcelona | Spain | ||||
| Hospital Sant Pau |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Late Lumen Loss |
Late lumen loss determinated by control angiography |
| 6 months |
| Binary restenosis rate | 6 months |
| Barcelona |
| Spain |
| Hospital TrĂas i Pujol | Barcelona | Spain |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |