BIOSOLVE-III Study is a pre-market, prospective, multi-center trial to assess the acute clinical performance of the DREAMS 2G Drug-Eluting Coronary Scaffold in de novo coronary artery lesions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Implanttaion fo the DREAMS 2G Scaffold
Interventional Cardiology Middelheim Hospital (ZNA Middelheim)
Antwerp, Belgium
Segeberger Kliniken GmbH
Bad Segeberg, Germany
Vivantes Klinikum Friederichshain,
Berlin, Germany
Amper Kliniken AG
Dachau, Germany
Acute performance of the DREAMS 2G
Acute performance of the DREAMS 2G assessed by procedure success. Procedure success is defined as: Procedure Success is defined as achievement of a final diameter stenosis of \<30% by QCA (using any percutaneous method) without the occurrence of death, Q-wave or non-Q-wave MI, or repeat revascularization of the target lesion during the hospital stay
Time frame: During the hospital stay to a maximum of 7 days post study Procedure
Target Lesion Failure (TLF)
TLF defined as a composite of Cardiac Death, Target Vessel Q-wave or non-Q wave Myocardial Infarction (MI)\*\*, Coronary Artery Bypass Grafting (CABG), clinically driven Target Lesion Revascularization (TLR)
Time frame: 1, 6 12, 24 and 36 months post procedure
Scaffold thrombosis rate
Time frame: 1, 6 12, 24 and 36 months post procedure
Binary in-scaffold and in-segment restenosis rate
Time frame: 12-months
% in-scaffold and in-segment diameter stenosis
Time frame: 12-months
In-segment late lumen loss
Time frame: 12-months
In-scaffold late lumen loss
Time frame: 12-months
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Städtische Kliniken Neuss
Neuss, Germany
Universitätsmedizin Rostock
Rostock, Germany
Thoraxcenter, Erasmus Medical Center
Rotterdam, Netherlands
Universitätsklinik Inselspitalspital Bern
Bern, Switzerland