The 001-DIOR Multicenter Registry

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eurocor GmbH
ClinicalTrials.gov Identifier:
NCT01375465
First received: June 16, 2011
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Coronary Artery Disease
Device: DIOR drug-eluting PTCA balloon
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Eurocor GmbH:

Primary Outcome Measures:
  • Major adverse cardiac events (MACE) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    MACE rate defined as the rate of cardiac death and/or myocardial infarction (MI) and/or target lesion revascularization (TLR)


Secondary Outcome Measures:
  • target vessel revascularization (TVR) rate, either symptom or ischemia-driven [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Segment treated thrombosis (STT), according to ARC definitions [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Late Lumen Loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Late lumen loss determinated by control angiography

  • Binary restenosis rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2011
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375465

Locations
Spain
Hospital Sant Pau
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
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
  More Information

No publications provided

Responsible Party: Eurocor GmbH
ClinicalTrials.gov Identifier: NCT01375465     History of Changes
Other Study ID Numbers: Eur-002
Study First Received: June 16, 2011
Last Updated: September 20, 2013
Health Authority: Spain: Ethics Committee

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014