The 001-DIOR Multicenter Registry

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01375465
• Other study ID #: Eur-002
• Status: Active, not recruiting
• Phase: Phase 4
• First received: June 16, 2011
• Last updated: September 20, 2013
• Start date: February 2011

Study information

• Verified date: September 2013
• Source: Eurocor GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• DIOR drug-eluting PTCA balloon
Treatment for 45 seconds with the DIOR balloon (3 µg/mm2 Paclitaxel concentration on balloon surface)

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona
Spain	Hospital Sant Pau	Barcelona
Spain	Hospital Trías i Pujol	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Eurocor GmbH

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	target vessel revascularization (TVR) rate, either symptom or ischemia-driven		6 months	Yes
Secondary	Segment treated thrombosis (STT), according to ARC definitions		6 months	Yes
Secondary	Late Lumen Loss	Late lumen loss determinated by control angiography	6 months	No
Secondary	Binary restenosis rate		6 months	No