Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatment dior drug-eluting ptca balloon
Phase phase 4
Sponsor Eurocor GmbH
Start date February 2011
End date July 2013
Trial size 50 participants
Trial identifier NCT01375465, Eur-002

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
One arm observational registry using the Dior paclitaxel eluting balloon for the treatment of de novo ostial bifurcated lesions.
dior drug-eluting ptca balloon
Treatment for 45 seconds with the DIOR balloon (3 µg/mm2 Paclitaxel concentration on balloon surface)

Primary Outcomes

Measure
Major adverse cardiac events (MACE)
time frame: 6 months

Secondary Outcomes

Measure
target vessel revascularization (TVR) rate, either symptom or ischemia-driven
time frame: 6 months
Segment treated thrombosis (STT), according to ARC definitions
time frame: 6 months
Late Lumen Loss
time frame: 6 months
Binary restenosis rate
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The 001-DIOR Multicenter Registry (A Novel Percutaneous Coronary Intervention With the New Paclitaxel-eluting Balloon DIOR in Ostial Bifurcated Lesions)
Principal investigator Antonio Serra, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by Eurocor GmbH.