Health Trials

Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold (RMS) System in Subjects With Coronary Artery Lesions

ConditionsCoronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCoronary Artery DiseaseMyocardial IschemiaAcute Coronary SyndromeAngina Pectoris
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTeleflex

About this trial

The objective of this study is to assess the safety and efficacy of the Freesolve resorbable magnesium scaffold (RMS) in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to the Xience coronary drug-eluting stent (DES) system

Eligibility criteria

Qualifiers

Subject is ≥ 18 years and ≤ 80 years of age

Subject has provided written informed consent as approved by the Ethics Committee / Institutional Review Board (IRB) of the respective clinical site prior to the study related procedures

Subject is eligible for PCI according to the applicable guidelines

Subject is an acceptable candidate for coronary artery bypass surgery

Disqualifiers

Subject is hemodynamically stable with documented declining cardiac biomarkers;

Target lesion(s) to be treated are not located in the culprit vessel(s) and are not culprit lesion(s)

Subject is eligible for Dual Antiplatelet Therapy (DAPT) with aspirin plus either clopidogrel, prasugrel, ticagrelor or ticlopidine

Documented left ventricular ejection fraction (LVEF) ≥ 30% within 6 months prior to or during the procedure (prior to randomization)

Trial design

Treatments tested in this trial

  • Freesolve RMS
  • Xience DES

Treatment groups

1,859 Participants
are divided into 2 treatment groups

Locations

1
MedStar Washington Hospital Center20010, Washington D.C.District of Columbia, United States

Sponsors and collaborators

Teleflex

Lead sponsor

Source ClinicalTrials.gov