First in Men Study: BIOMAG-I

Status Active, not recruiting

Clinical Trial Summary

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

Clinical Trial Description

Clinical follow-up visits will take place at 1, 6, and 12 months and annually thereafter until 60 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

Related Conditions & MeSH terms

Coronary Artery Disease

Clinical Trial Details

NCT number	NCT04157153
Study type	Interventional
Source	Biotronik AG
Contact
Status	Active, not recruiting
Phase	N/A
Start date	April 27, 2020
Completion date	February 2027

View Details

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