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

NCT07091682 | Recruiting DMC

• 1 other identifier: C2301
• Study Type: interventional
• Target: 100
• Locations: 5 countries
• Sites: 8

Brief Summary

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.

Conditions

Coronary Artery Disease; Atherosclerosis of Coronary Artery; Myocardial Ischemia; Ischemic Heart Disease; Acute Coronary Syndromes; Angina Pectoris

Keywords

Resorbable Magnesium Scaffold; Sirolimus; RMS; Drug eluting absorbable metal scaffold

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure

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

  12 Months

Study Arms (1)

Treatment

EXPERIMENTAL

All subjects will be implanted with the Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System (Freesolve 35- and 40-mm scaffold) and followed up until 60 months.

Device: Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold

Interventions

Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold DEVICE

Subjects with symptomatic coronary artery disease who qualify for percutaneous coronary intervention (PCI) will be treated with a sirolimus eluting resorbable coronary Magnesium scaffold

Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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
• 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
• 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)

Sponsors & Collaborators

• Biotronik AG: lead

Study Sites (8)

Katholisches Krankenhaus "St. Johann Nepomuk"

Erfurt, 99097, Germany

RECRUITING

Universitätsklinikum Halle (Saale)

Halle, 6120, Germany

RECRUITING

Klinikverbund Allgäu gGmbH

Immenstadt and Kempten, 87509, Germany

RECRUITING

Centro Cardiologico Monzino SpA

Milan, 20138, Italy

RECRUITING

Azienda Ospedaliera Universitaria Integrata Verona

Verona, 37126, Italy

NOT YET RECRUITING

Pauls Stradins Clinical University Hospital

Riga, 1002, Latvia

RECRUITING

Miedziowe Centrum Zdrowia S.A

Lubin, 59-311, Poland

RECRUITING

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia; Acute Coronary Syndrome; Angina Pectoris

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Flavio Luciano Ribichini, Prof. Dr.

  Azienda Ospedaliera Universitaria Integrata Verona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Widmann, PhD

CONTACT

0041 75 429 5530; barbara.widmann@biotronik.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 29, 2025
• Study Start: February 18, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2031
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

DE (3); ES (1); IT (2); LA (1); PL (1)