The 001-DIOR Multicenter Registry

Eurocor

Status and phase

Unknown

Phase 4

Conditions

Coronary Artery Disease

Treatments

Device: DIOR drug-eluting PTCA balloon

Study type

Interventional

Funder types

Industry

Identifiers

NCT01375465

Eur-002

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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