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3rd Generation Resorbable Magnesium Scaffolds vs Biodegradable Polymer Stents in NSTE/ACS
Sponsor: Konstantinos Toutouzas
Summary
This is a multicentre, prospective, randomized controlled trial that will investigate the role and performance of the 3rd generation resorbable magnesium scaffolds "DREAMS 3G" labeled under the name "Freesolve" vs contemporary biodegradable polymer scaffolds in non ST-segment elevation acute coronary syndromes. Patients fulfilling the eligibility criteria will be enrolled and undergo PCI with either Freesolve or Orsiro platforms for the culprit lesion only. They will be followed-up for 12 months (1, 6 and 12 months). The primary endopoint will be Target Lesion Failure as defined by ARC definitions.
Official title: 3rd Generation Resorbable Magnesium Scaffolds vs Biodegradable Polymer Drug Eluting Stents in Patients With Non ST-segment Elevation Acute Coronary Syndromes: the RESORB-ACS Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2024-10-01
Completion Date
2027-12-31
Last Updated
2024-05-22
Healthy Volunteers
No
Interventions
Percutaneous coronary intervention
Percutaneous coronary intervention with scaffold implantation in patients with NSTE/ACS
Locations (7)
CHU Saint-Pierre
Brussels, Belgium
UZ Brussel
Brussels, Belgium
UZ Leuven
Leuven, Belgium
UC Louvain
Leuven, Belgium
Hippocration Hospital
Athens, Attica, Greece
Hippokration hospital
Thessaloniki, Greece
Geneva University Hospitals
Geneva, Switzerland