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The 001-DIOR Multicenter Registry

Sponsor
Eurocor GmbH (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01375465
Collaborator
(none)
50
Enrollment
3
Locations
1
Arm
16.7
Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: DIOR drug-eluting PTCA balloon
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The 001-DIOR Multicenter Registry (A Novel Percutaneous Coronary Intervention With the New Paclitaxel-eluting Balloon DIOR in Ostial Bifurcated Lesions)
Study Start Date :
Feb 1, 2011
Actual Primary Completion Date :
Jul 1, 2013

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Major adverse cardiac events (MACE) [6 months]

    MACE rate defined as the rate of cardiac death and/or myocardial infarction (MI) and/or target lesion revascularization (TLR)

Secondary Outcome Measures

  1. target vessel revascularization (TVR) rate, either symptom or ischemia-driven [6 months]

  2. Segment treated thrombosis (STT), according to ARC definitions [6 months]

  3. Late Lumen Loss [6 months]

    Late lumen loss determinated by control angiography

  4. Binary restenosis rate [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital del Mar Barcelona Spain
2 Hospital Sant Pau Barcelona Spain
3 Hospital Trías i Pujol Barcelona Spain

Sponsors and Collaborators

  • Eurocor GmbH

Investigators

  • Principal Investigator: Antonio Serra, MD, PhD, Hospital Sant Pau, Barcelona
  • Principal Investigator: Beatriz Vaquerizo, MD, PhD, Hospital Sant Pau, Barcelona

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eurocor GmbH
ClinicalTrials.gov Identifier:
NCT01375465
Other Study ID Numbers:
  • Eur-002
First Posted:
Jun 17, 2011
Last Update Posted:
Sep 23, 2013
Last Verified:
Sep 1, 2013
Additional relevant MeSH terms:
Coronary Artery Disease

Study Results

No Results Posted as of Sep 23, 2013