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The 001-DIOR Multicenter Registry

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ClinicalTrials.gov Identifier: NCT01375465
Recruitment Status : Unknown
Verified September 2013 by Eurocor GmbH.
Recruitment status was:  Active, not recruiting
First Posted : June 17, 2011
Last Update Posted : September 23, 2013
Sponsor:
Information provided by (Responsible Party):
Eurocor GmbH

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 2011
Actual Primary Completion Date : July 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. Major adverse cardiac events (MACE) [ Time Frame: 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 [ Time Frame: 6 months ]
  2. Segment treated thrombosis (STT), according to ARC definitions [ Time Frame: 6 months ]
  3. Late Lumen Loss [ Time Frame: 6 months ]
    Late lumen loss determinated by control angiography

  4. Binary restenosis rate [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01375465


Locations
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Spain
Hospital del Mar
Barcelona, Spain
Hospital Sant Pau
Barcelona, Spain
Hospital Trías i Pujol
Barcelona, Spain
Sponsors and Collaborators
Eurocor GmbH
Investigators
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Principal Investigator: Antonio Serra, MD, PhD Hospital Sant Pau, Barcelona
Principal Investigator: Beatriz Vaquerizo, MD, PhD Hospital Sant Pau, Barcelona

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Responsible Party: Eurocor GmbH
ClinicalTrials.gov Identifier: NCT01375465     History of Changes
Other Study ID Numbers: Eur-002
First Posted: June 17, 2011    Key Record Dates
Last Update Posted: September 23, 2013
Last Verified: September 2013
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action