NCT04157153

First in Men Study: BIOMAG-I

BIOTRONIK - Safety and Clinical Performance of the - Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System (DREAMS 3G) in the Treatment of Subjects With de Novo Lesions in Native Coronary Arteries

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Biotronik AG · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold	Subjects with symptomatic coronary artery disease who qualify for percutaneous coronary intervention (PCI) will be treated with a sirolimus eluting resorbable coronary Magnesium scaffold

Timeline

• Start date: 2020-04-27
• Primary completion: 2022-08-01
• Completion: 2027-02-01
• First posted: 2019-11-08
• Last updated: 2022-07-22

Locations

14 sites across 8 countries: Austria, Belgium, Germany, Netherlands, Poland, Spain, Sweden, Switzerland