Status:
UNKNOWN
BiOSS Study (BiOSS LIM C Stent Registry in Bifurcated Lesions)
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
The BIOSS Lim C pharmacoactive Stent has characteristics of design that makes it very suitable for the treatment of bifurcational lesions . The objective of the study is providing deeper knowledge int...
Detailed Description
The BIOSS Lim C pharmacoactive Stent has characteristics of design that makes it very suitable for the treatment of bifurcational lesions . The objective of the study is providing deeper knowledge int...
Eligibility Criteria
Inclusion
- Age over 18 years.
- Clinical indication of coronary angioplasty in bifurcated lesion.
- Bifurcated lesions with both distal branches at least 2 mm in diameter.
- The lesion must be located in the main branch, with a severe stenosis by visual estimation at some point in the main branch, with or without involvement of the lateral branch.
- Express acceptance and signature of informed consent.
Exclusion
- Express rejection of the patient to participate in the study.
- Exclusive involvement of the lateral branch (Medina lesion 001).
- Contraindication for antiplatelet treatment.
- Lesions due to restenosis.
- Lesions in saphenous grafts.
- Total chronic occlusions.
- Cardiogenic shock.
Key Trial Info
Start Date :
August 16 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03475563
Start Date
August 16 2018
End Date
December 30 2019
Last Update
November 27 2019
Active Locations (3)
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1
Hospital Universitari Parc Taulí
Sabadell, Barcelona, Spain, 08208
2
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
3
Hospital Universitario de León
León, Spain, 24071