The 001-DIOR Multicenter Registry

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: DIOR drug-eluting PTCA balloon

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital del Mar
  • Barcelona, Spain
    • Hospital Sant Pau
  • Barcelona, Spain
    • Hospital Trias i Pujol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Dior; 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; Treatment for 45 seconds with the DIOR balloon (3 µg/mm2 Paclitaxel concentration on balloon surface)

What is the study measuring?

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
Binary restenosis rate		6 months
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

Collaborators and Investigators

• Sponsor: Eurocor GmbH
• Investigators: Principal Investigator: Antonio Serra, MD, PhD, Hospital Sant Pau, Barcelona; Principal Investigator: Beatriz Vaquerizo, MD, PhD, Hospital Sant Pau, Barcelona

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (ACTUAL): July 1, 2013

Study Registration Dates

• First Submitted: June 16, 2011
• First Submitted That Met QC Criteria: June 16, 2011
• First Posted (ESTIMATE): June 17, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): September 23, 2013
• Last Update Submitted That Met QC Criteria: September 20, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: Eur-002