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

NCT06409117 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2024-05-22

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Percutaneous coronary intervention

Percutaneous coronary intervention with scaffold implantation in patients with NSTE/ACS

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Saint Pierre

    collaborator OTHER

  • Université Catholique de Louvain

    collaborator OTHER

  • University Hospital of Leuven Leuven

    collaborator OTHER

  • University of Patras

    collaborator OTHER

  • Ippokrateio General Hospital of Thessaloniki

    collaborator OTHER

  • Konstantinos Toutouzas

    lead OTHER

Principal Investigators

  • Leonidas Koliastasis, MD, PhD · National and Kapodistrian University of Athens, CHU Saint-Pierre

  • Konstantinos Toutouzas, Professor · National and Kapodistrian University of Athens

  • Quentin de Hemptinne, Professor · Centre Hospitalier Universitaire Saint Pierre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Belgium
  • Greece
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06409117 on ClinicalTrials.gov