The 001-DIOR Multicenter Registry
1 other identifier
interventional
50
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 coronary-artery-disease
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 16, 2011
CompletedFirst Posted
Study publicly available on registry
June 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedSeptember 23, 2013
September 1, 2013
2.4 years
June 16, 2011
September 20, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
6 months
Binary restenosis rate
6 months
Study Arms (1)
Dior
OTHEROne arm observational registry using the Dior paclitaxel eluting balloon for the treatment of de novo ostial bifurcated lesions.
Interventions
Treatment for 45 seconds with the DIOR balloon (3 µg/mm2 Paclitaxel concentration on balloon surface)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eurocor GmbHlead
Study Sites (3)
Hospital del Mar
Barcelona, Spain
Hospital Sant Pau
Barcelona, Spain
Hospital Trías i Pujol
Barcelona, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antonio Serra, MD, PhD
Hospital Sant Pau, Barcelona
- PRINCIPAL INVESTIGATOR
Beatriz Vaquerizo, MD, PhD
Hospital Sant Pau, Barcelona
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2011
First Posted
June 17, 2011
Study Start
February 1, 2011
Primary Completion
July 1, 2013
Last Updated
September 23, 2013
Record last verified: 2013-09