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

NCT ID: NCT07091682

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-18
• Study Completion Date: 2031-06-30

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.

Detailed Description

In the study presented here, an extension of the Freesolve size range (35 and 40 mm scaffold length) will be investigated with the aim of assessment the safety and clinical performance of 35 and 40 mm Freesolve in de novo coronary artery lesions up to 38 mm in length to support CE certification of these sizes.

BIOMAG-LL is a pre-marketing study. It is a prospective, international, multi-center, single arm trial. The primary endpoint of the study will be Target Lesion Failure (TLF) rate at 12 months. Clinical follow-up will be conducted at 1, 6, 12, 36, and 60 months post-procedure.

The total duration of the study is approximately six and a half years, including the fifteen-month recruitment phase and the five-year follow-up period. A sample size of 100 patients is expected.

In addition, it is intended to conduct a pharmacokinetic substudy. The objective of this substudy is to describe the pharmacokinetics of sirolimus delivered by Freesolve. For this purpose, 15 patients will be prospectively enrolled in the substudy with a whole blood sample collected up to seven days after the procedure.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

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.

Group Type: EXPERIMENTAL

Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold

Intervention Type: 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

Interventions

Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject is ≥ 18 years and ≤ 80 years of age

2. 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

3. Subject is eligible for PCI according to the applicable guidelines

4. Subject is an acceptable candidate for coronary artery bypass surgery

5. 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:

1. Subjects with a maximum of two single de novo target lesions each in separate native coronary arteries

2. 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)

3. 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

4. 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.

5. Target lesion must have a Thrombolysis In Myocardial Infarction (TIMI) flow ≥1

Exclusion Criteria

• 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)

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

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

8. Subject is willing and able to comply with protocol requirements, including completion of study visits for the duration of the study

1. Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study

2. 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.

3. 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)

4. 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)

5. 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)

6. 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)

7. Life expectancy less than 1 year

8. Planned surgery or dental surgical procedure within 6 months after index procedure, unless DAPT can be maintained.

9. In the investigator's opinion subject will not be able to comply with the follow-up requirements

10. 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

11. Subject has had a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure .

12. Subject with active bleeding disorder, active coagulopathy, or any other reason, who is ineligible for DAPT.

13. Subject is currently participating or plans to participate in another study with an investigational device or an investigational drug

1. Target vessel has been previously treated and the target lesion is within 5 mm proximal or distal to the previously treated lesion.

2. Left main coronary artery disease

3. Target lesion was totally occluded (100% stenosis)

4. Thrombus in target vessel

5. Future planned staged PCI either in target or non-target vessel

6. Ostial target lesion within the left descending (LAD), left circumflex (LCx), or right coronary artery (within 5.0 mm of vessel origin)

7. Target lesion involves a side branch ≥ 2.0 mm in diameter that requires a two-device strategy after pre-dilatation.

8. Target lesion is located in or supplied by an arterial or venous bypass graft.

10. The target lesion requires treatment with the device other than the non-compliant balloon and/or cutting/scoring balloon prior to scaffold placement (including but not limited to atherectomy devices, intravascular lithotripsy, drug-coated balloons etc.)

11. Target vessel was treated with brachytherapy any time prior to the index procedure.

12. Unsuccessful pre-dilatation, defined as residual stenosis > 20% (by visual estimation) and / or angiographic complications (e.g. distal embolization, side branch closure, flow-limiting dissections)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Flavio Luciano Ribichini, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera Universitaria Integrata Verona

Locations

Katholisches Krankenhaus "St. Johann Nepomuk"

Erfurt, , Germany

Site Status: RECRUITING

Universitätsklinikum Halle (Saale)

Halle, , Germany

Site Status: RECRUITING

Klinikverbund Allgäu gGmbH

Immenstadt and Kempten, , Germany

Site Status: RECRUITING

Centro Cardiologico Monzino SpA

Milan, , Italy

Site Status: RECRUITING

Azienda Ospedaliera Universitaria Integrata Verona

Verona, , Italy

Site Status: NOT_YET_RECRUITING

Pauls Stradins Clinical University Hospital

Riga, , Latvia

Site Status: RECRUITING

Miedziowe Centrum Zdrowia S.A

Lubin, , Poland

Site Status: RECRUITING

Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status: RECRUITING

Countries

Germany; Italy; Latvia; Poland; Spain

Central Contacts

Barbara Widmann, PhD

Role: CONTACT

barbara.widmann@biotronik.com

0041 75 429 5530

Facility Contacts

Henning Ebelt, Prof. Dr.

Role: primary

Daniel Sedding, Prof. Dr.

Role: primary

Jan Torzewski, Prof. Dr.

Role: primary

Stefano Galli, Dr.

Role: primary

Flavio Luciano Ribichini, Prof. Dr.

Role: primary

Andrejs Erglis, Prof. Dr.

Role: primary

Adrian Wlodarczak, Dr. hab. n. med.

Role: primary

Manel Sabaté, Dr.

Role: primary

Other Identifiers

C2301

Identifier Type: -

Identifier Source: org_study_id