Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions

Recruiting now · Not applicable

Conditions studied: Coronary Artery Disease, Atherosclerosis of Coronary Artery, Myocardial Ischemia, Ischemic Heart Disease, Acute Coronary Syndromes, Angina Pectoris

In brief

The study objective is the assessment of safety and clinical performance of Freesolve 35- and 40-mm in de novo coronary artery lesions up to 38 mm length.

Key facts

Study ID: NCT07091682
Run by: Biotronik AG
People needed: 100
Starts: 2025-02-18
Expected to finish: 2031-06-01
Last updated by the study team: 2026-07-08

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Clinical Inclusion Criteria
Subject is ≥ 18 years and ≤ 80 years of age
Subject has provided written informed consent as approved by the Independent Ethical Committee (IEC) or 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
Subjects with stable or unstable angina pectoris, documented silent ischemia/abnormal physiologic testing or hemodynamically stable non-ST elevation myocardial infarction (NSTEMI) patients without angiographic evidence of thrombus at target lesion
Note: STEMI patients may be eligible for the study for treatment of selected non-culprit lesions, if:
Subject and target lesion(s) meet all inclusion and no exclusion criteria and consent occurs at least ≥ 72 hours after successful treatment of the culprit lesion(s) [lesion(s) causing the acute STEMI];
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, cangrelor or ticlopidine
Documented left ventricular ejection fraction (LVEF) ≥ 30% within 6 months prior to or during the procedure (prior to enrollment)
Subject is willing and able to comply with protocol requirements, including completion of study visits for the duration of the study
Angiographic Inclusion Criteria
Subjects with a maximum of two single de novo target lesions each in separate native coronary arteries
Target vessel must have a reference diameter between 2.7-4.2 mm by visual estimation, which may be assisted by Quantitative Coronary Angiography (QCA) / Intravascular Ultrasound (IVUS) / Optical Coherence Tomography (OCT)
Target lesion must be >28 mm and ≤ 38 mm in length by operator visual estimation, which may be assisted by QCA / IVUS / OCT, and should be amenable to treatment with a single study device
Target lesion stenosis ≥ 50% and < 100% by operator visual estimation, which may be assisted by QCA / IVUS / OCT. Target lesion stenosis < 70% by visual estimation, should have clinical justification for treatment as per local standards.
Target lesion must have a Thrombolysis In Myocardial Infarction (TIMI) flow ≥1

You may not qualify if…

Clinical Exclusion Criteria
Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study
Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with STEMI < 72 hours prior to the index procedure.
Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment.
Subject has undergone prior PCI within the target vessel during the last 12 months prior to the index procedure or prior PCI within a non-target vessel <72 hours prior to the index procedure (time window is defined as the time from the end of previous intervention to the start of index procedure)
Subject is on dialysis or with impaired renal function (serum creatinine > 2.5 mg/dL or 221 µmol/L, determined within 72 hours prior to the index procedure)
Subject has a known allergy to contrast medium that cannot be adequately premedicated, or any known allergy to aspirin, P2Y12 inhibitors, both heparin and bivalirudin, sirolimus (or similar limus drugs), poly L-lactide, the scaffold material (magnesium, aluminum, tantalum)
Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are permitted) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus; diabetes mellitus is permitted)
Life expectancy less than 1 year
Planned surgery or dental surgical procedure within 6 months after index procedure, unless DAPT can be maintained.
In the investigator's opinion subject will not be able to comply with the follow-up requirements
Subjects under oral anticoagulation therapy (OAC) prior to index procedure unless DAPT + OAC (i.e. triple therapy) can be maintained for a minimum of 1 month
Subject has had a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure .
Subject with active bleeding disorder, active coagulopathy, or any other reason, who is ineligible for DAPT.
Subject is currently participating or plans to participate in another study with an investigational device or an investigational drug
Angiographic Exclusion Criteria:
Target vessel has been previously treated and the target lesion is within 5 mm proximal or distal to the previously treated lesion.
Left main coronary artery disease
Target lesion was totally occluded (100% stenosis)
Thrombus in target vessel
Future planned staged PCI either in target or non-target vessel
Ostial target lesion within the left descending (LAD), left circumflex (LCx), or right coronary artery (within 5.0 mm of vessel origin)
Target lesion involves a side branch ≥ 2.0 mm in diameter that requires a two-device strategy after pre-dilatation.
Target lesion is located in or supplied by an arterial or venous bypass graft.
Target lesion with excessive tortuosity proximal to or within the lesion based on visual estimation or heavily calcified target lesion which cannot be adequately pre-dilated by a non-compliant and/or cutting/scoring balloon as described in angiographic exclusion criteria 10.

Where it is running

Katholisches Krankenhaus "St. Johann Nepomuk" — Erfurt, Germany (enrolling)
Universitätsklinikum Halle (Saale) — Halle, Germany (enrolling)
Klinikverbund Allgäu gGmbH — Immenstadt and Kempten, Germany (enrolling)
Klinikum der Ludwig-Maximilians-Universität München — München, Germany (enrolling)
Semmelweis University — Budapest, Hungary (enrolling)
Centro Cardiologico Monzino SpA — Milan, Italy (enrolling)
Azienda Ospedaliera Universitaria Integrata Verona — Verona, Italy (enrolling)
Pauls Stradins Clinical University Hospital — Riga, Latvia (enrolling)
Miedziowe Centrum Zdrowia S.A — Lubin, Poland (enrolling)
Hospital Clinic de Barcelona — Barcelona, Spain (enrolling)
Hospital de la Princesa — Madrid, Spain (enrolling)
Hospital Clinic Universitario de Valladolid — Valladolid, Spain (enrolling)
University Hospital Basel — Basel, Switzerland (enrolling)
HUG Hospitaux Universitaires de Geneve — Geneva, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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