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First in Men Study: BIOMAG-I

2019-11-14 17:39:54 | BioPortfolio

Summary

A prospective, multi-center, first-in-man trial. Up to 115 subjects will be enrolled.

Description

Clinical follow-up visits will take place at 1, 6, and 12 months and annually thereafter until 36 months post procedure.

All subjects will undergo an angiographic follow-up at 6- and 12-month follow up.

IVUS, (including IVUS-VH documentation) and OCT will be performed for all subjects at 6-month and 12-month follow-up (if the safety of the subject allows it and as per the investigator's decision).

Vasomotion will be assessed angiographically with Acetylcholine followed by Nitroglycerine at 12 months follow up in a subgroup of subjects, upon the investigators discretion and if subject consents.

Study Design

Conditions

Coronary Artery Disease

Intervention

Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold

Location

Medizinische Universität Graz
Graz
Austria

Status

Not yet recruiting

Source

Biotronik AG

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-11-14T17:39:54-0500

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