The 001-DIOR Multicenter Registry

Study Overview
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Brief Summary
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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.

Official Title
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The 001-DIOR Multicenter Registry (A Novel Percutaneous Coronary Intervention With the New Paclitaxel-eluting Balloon DIOR in Ostial Bifurcated Lesions)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: DIOR drug-eluting PTCA balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: De novo bifurcated lesions 001 of Medina classification, with significant stenosis only in the ostium of the side branch and a reference vessel diameter is bigger or equal 2.0mm; the DIOR balloon will be used to the treat the side branch. The patient has clinical evidence of myocardial ischemia (stable or unstable angina, acute and non acute myocardial infarction, silent ischemia: ECG, exercise test, etz...) As the maximal length of the DIORTM balloon is 30 mm, all eligible lesions should be no longer than 25 mm to ensure an adequate drug elution in the treated segment, avoiding the phenomenon of geographical miss . Target lesion(s) stenosis is more or equal 50% by visual estimation. Exclusion Criteria: Cardiogenic shock Any serious disease that might limit patient survival to less than one year Inability to perform clinical follow-up for a period of 1 year Left main bifurcation lesions: ostial left circumflex or ostial left anterior descending artery stenosis. Lesion length > 25 mm Target vessel reference diameter < 2mm Stenosis < 50% of the reference luminal diameter Severe angiographic calcification at the level of the target lesion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dior<br>One arm observational registry using the Dior paclitaxel eluting balloon for the treatment of de novo ostial bifurcated lesions. | Device: DIOR drug-eluting PTCA balloon<br>* Treatment for 45 seconds with the DIOR balloon (3 µg/mm2 Paclitaxel concentration on balloon surface)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Late Lumen Loss | Late lumen loss determinated by control angiography | 6 months | 
| Binary restenosis rate |  | 6 months |