BIfurcation Optimal Treatment Strategy With LYMus Eluting Dedicated Bifurcation Versus Convention Stent Randomized Study (BIOSS LIM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01430364|
Recruitment Status : Unknown
Verified December 2013 by Medica Cor Heart Hospital.
Recruitment status was: Recruiting
First Posted : September 8, 2011
Last Update Posted : December 25, 2013
|Condition or disease||Intervention/treatment||Phase|
|Coronary Bifurcation Stenosis||Device: BIOSS LIM implantation Device: BIOSS Lim Device: CarloS||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||BIfurcation Optimal Treatment Strategy With LIMus Eluting Dedicated Bifurcation Versus Convention Stent Randomized Study|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||May 2014|
|Active Comparator: BIOSS implantation||
Device: BIOSS LIM implantation
BIOSS LIM is a dedicated bifurcation stent system with sirolymus elution.
Device: BIOSS Lim
- Major adverse cardiac events (MACE) [ Time Frame: 12 months ]death, myocardial infarction (MI), target vessel revascularization (TVR)
- Target lesion revascularization (TLR) [ Time Frame: 12 months ]Clinically driven revascularization rates.
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): NCT01430364
|Contact: Dobrin Vassilev, MD, PhDemail@example.com|
|Contact: Kristiyan Ivanov, MDfirstname.lastname@example.org|
|Medica Cor Heart Hospital||Recruiting|
|Ruse, Bulgaria, 7000|
|Contact: Dobrin Vassilev, MD, PhD 00359886846550 email@example.com|
|Contact: Kristiyan Ivanov, MD 00359884460101 firstname.lastname@example.org|