BIOSOLVE-II
NCT01960504
First in man study of the DREAMS 2nd generation drug-eluting absorbable metal scaffold
Conclusions
- Magmaris demonstrated a favorable safety and performance until 24-month follow-up
- The rate of definite/probable scaffold thrombosis remained at 0% at 24 months
Study Design
Prospective, multi-center, first-in-man trial to evaluate the safety and performance of Magmaris in 123 patients with a maximum of two de novo lesions in two separate coronary arteries
Principal investigator:
Prof. Michael Haude, Neuss, Germany
* Two patients who did not receive an implant were used for calculation of device and procedural success only.
![Image Study Design](/sites/default/files/styles/site_width/public/migrated_images/bio26613_553x368.jpg?itok=Z377lRLS)
Primary endpoint:
In-segment Late Lumen Loss (LLL) at 6-month follow-up
Secondary endpoints (selected):
- TLF defined as a composite of cardiac death, target-vessel myocardial infarction and clinically-driven target lesion revascularization (cd-TLR) at 24 months
- Definite/probable scaffold thrombosis at 24 months
Clinical Results
![](/sites/default/files/styles/site_width/public/migrated_images/bio26731_1106x368.jpg?itok=glsK9YVD)
![](/sites/default/files/migrated_images/bio26732_1106x368.jpg)
![](/sites/default/files/migrated_images/bio26603_1106x368.jpg)
![](/sites/default/files/migrated_images/bio26604_1106x368.jpg)
Downloads
![Magmaris Image](/sites/default/files/styles/site_width/public/migrated_images/bio24342_553x246.jpg?itok=8wNKfbc-)
![Magmaris Image](/sites/default/files/styles/site_width/public/migrated_images/bio23931_553x246.jpg?itok=c_sd82rc)
Vascular Intervention
Clinical StudyFirst in man trial with DREAMS (Drug Eluting Absorbable Metal Scaffold)
Disclaimer
Magmaris is not available in the US.
© BIOTRONIK AG – All rights reserved.
Specifications are subject to modification, revision and improvement.
1 TLF defined as a composite of cardiac death, target-vessel MI and cd-TLR
2 Two deaths of unknown cause were adjudicated as cardiac deaths