Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
50 participants
INTERVENTIONAL
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dior
One arm observational registry using the Dior paclitaxel eluting balloon for the treatment of de novo ostial bifurcated lesions.
DIOR drug-eluting PTCA balloon
Treatment for 45 seconds with the DIOR balloon (3 µg/mm2 Paclitaxel concentration on balloon surface)
Interventions
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DIOR drug-eluting PTCA balloon
Treatment for 45 seconds with the DIOR balloon (3 µg/mm2 Paclitaxel concentration on balloon surface)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Eurocor GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Antonio Serra, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Sant Pau, Barcelona
Beatriz Vaquerizo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Sant Pau, Barcelona
Locations
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Hospital del Mar
Barcelona, , Spain
Hospital Sant Pau
Barcelona, , Spain
Hospital Trías i Pujol
Barcelona, , Spain
Countries
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Other Identifiers
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Eur-002
Identifier Type: -
Identifier Source: org_study_id