BIOSOLVE-II

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.

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Image Study Design

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

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Downloads


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Magmaris Image

Vascular Intervention

Resorbable Magnesium ScaffoldIn a Class of Its Own

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Magmaris Image

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