Pre-market Study of the DREAMS 2G Drug Eluting Absorbable Metal Scaffold (BIOSOLVE-III)
NCT02716220 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61
Last updated 2020-01-18
Summary
BIOSOLVE-III Study is a pre-market, prospective, multi-center trial to assess the acute clinical performance of the DREAMS 2G Drug-Eluting Coronary Scaffold in de novo coronary artery lesions.
Conditions
- Coronary Artery Disease
- Coronary Artery Stenosis
Interventions
- DEVICE
-
Percutaneous Coronary Intervention
Implanttaion fo the DREAMS 2G Scaffold
Sponsors & Collaborators
-
Biotronik AG
lead INDUSTRY
Principal Investigators
-
Michael Haude, MD · Städtische Kliniken Neuss
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-03-31
- Primary Completion
- 2017-12-31
- Completion
- 2019-08-31
Countries
- Belgium
- Germany
- Netherlands
- Switzerland
Study Locations
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