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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Freesolve RMS

    Device

    Freesolve Sirolimus-Eluting Coronary Resorbable Magnesium Scaffold (RMS) System, a drug-eluting balloon-expandable resorbable scaffold

  • Xience DES

    Device

    Xience Everolimus Eluting Stent System

Treatment groups

1,859 Participants
are divided into 2 treatment groups
Group A: Freesolve RMSExperimental treatment 1 intervention
Group B: Xience DESActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Target Lesion Failure (TLF) rate at 12 months post-index procedure

The primary endpoint is Target Lesion Failure (TLF) at 12 months, a composite of Cardiac Death, Target Vessel Q-wave or non-Q wave MI, or clinically driven target lesion revascularization (TLR).

Time frame
12 months

Secondary outcomes

1

Procedure success

Procedure success defined as achievement of \< 30% final residual diameter stenosis \[by Quantitative Coronary Angiography (QCA) or visual estimation\] of the target lesion using the assigned study device only, without the occurrence of cardiac death, Q-wave or non-Q-wave MI, or repeat revascularization of the target lesion during the hospital stay

Time frame
Hospital Discharge (6-24 hours post-index procedure)
2

Device Success

Device Success defined as a final residual diameter stenosis of \< 30% by QCA or visual estimation, using the assigned device only with * successful delivery of the device to the target lesion, and * appropriate device deployment, and * successful removal of the delivery system

Time frame
Hospital Discharge (6-24 hours post-index procedure)
3

Target lesion failure (TLF)

TLF is defined as a composite of Cardiac Death, Target Vessel Q-wave or non-Q-wave myocardial infarction (MI), or clinically driven Target Lesion Revascularization (TLR)

Time frame
Time Frame: 1, 6 months and 2, 3, 4 and 5 years post-index procedure
4

Target Vessel Failure (TVF)

Target Vessel Failure (TVF), a composite of Cardiac Death, Target Vessel Q-wave or non-Q wave MI, or clinically driven Target Vessel Revascularization (TVR)

Time frame
1, 6, 12 months and 2, 3, 4 and 5 years post-index procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Teleflex

Lead sponsor

Source ClinicalTrials.gov
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