NCT01960504

First in Man Study of the DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold (BIOSOLVE-II)

BIOTRONIK - Safety and Clinical PerFormance of the Drug Eluting Absorbable Metal Scaffold (DREAMS 2nd Generation) in the Treatment of Subjects With de NOvo Lesions in NatiVE Coronary Arteries: BIOSOLVE-II

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Biotronik AG · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

BIOSOLVE-II is a prospective, international, multicenter, First in Man study. The purpose of this study is to assess the safety and clinical performance of the drug eluting absorbable metal scaffold (DREAMS 2nd Generation).

Conditions

• Coronary Artery Disease
• Coronary Artery Stenosis

Interventions

Type	Name	Description
DEVICE	Percutaneous Coronary Intervention (DREAMS) stenting

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-08-01
• Completion: 2020-05-01
• First posted: 2013-10-10
• Last updated: 2020-01-18

Locations

13 sites across 8 countries: Belgium, Brazil, Denmark, Germany, Netherlands, Singapore, Spain, Switzerland