BIOSOLVE-II is a prospective, international, multicenter, First in Man study. The purpose of this study is to assess the safety and clinical performance of the drug eluting absorbable metal scaffold (DREAMS 2nd Generation).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
123
OLV-Ziekenhuis Aalst
Aalst, Belgium
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil
Instituto do Coração - HCFMUSP
São Paulo, Brazil
In segment Late Lumen Loss
Time frame: 6 months post index procedure
Target Lesion Failure (TLF), defined as composite of cardiac death, target vessel Q-wave or non-Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularisation (TLR)
Time frame: 1, 6, 12, 24 and 36 months
Scaffold thrombosis rate
Time frame: 1, 6, 12, 24 and 36 months
In-scaffold and in-segment Binary Restenosis Rate
Time frame: 6 and 12 months
In-scaffold and in-segment Percent Diameter Stenosis
Time frame: 6 and 12 months
Late Lumen Loss in segment
Time frame: 12 months
Late Lumen Loss in scaffold
Time frame: 6 and 12 months
Procedure success
Procedure Success defined as achievement of a final diameter stenosis of \<30% by QCA, using any percutaneous method, without the occurrence of death, Q-wave or WHO defined non-Q-wave, or repeat revascularization of the target lesion during the hospital stay.
Time frame: During the hospital stay to a maximum of the first seven days post index procedure
Device success
Device Success is defined as a final residual diameter stenosis of \<30% by QCA, using the assigned device only * successful delivery of the scaffold to the target lesion site in the coronary artery * appropriate scaffold deployment * successful removal of the device * safe removal of the device in case of deployment failure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Aarhus University Hospital
Aarhus, Denmark
Universitäts-Herzzentrum Freiburg Bad Krozingen
Bad Krozingen, Germany
Segeberg Kliniken GmbH, Herzzentrum
Bad Segeberg, Germany
Vivantes Klinikum
Berlin, Germany
Städtische Kliniken Neuss - Lukaskrankenhaus
Neuss, Germany
Thoraxcentrum Twente
Enschede, Netherlands
National Heart Centre Singapore
Mistri Wing, Singapore
...and 3 more locations
Time frame: Day 0