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NOT YET RECRUITING
NCT06409117
PHASE4

3rd Generation Resorbable Magnesium Scaffolds vs Biodegradable Polymer Stents in NSTE/ACS

Sponsor: Konstantinos Toutouzas

View on ClinicalTrials.gov

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

DEVICE

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