Actively Recruiting
Safety and Clinical Performance of the Drug Eluting Resorbable Magnesium Scaffold (Freesolve) in Treating Long New Lesions in Native Coronary Arteries
Led by Biotronik AG · Updated on 2025-11-21
100
Participants Needed
8
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and clinical performance of the Freesolve Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System in treating long new coronary artery lesions up to 38 mm in length. This international, multi-center, single-arm trial aims to support certification of the 35- and 40-mm scaffold sizes. The study will measure Target Lesion Failure rates over 12 months and follow patients for up to five years after treatment. All participants will receive the Freesolve scaffold implanted in their coronary arteries. The trial includes a treatment phase where the device is implanted during percutaneous coronary intervention. Additionally, a pharmacokinetic substudy will enroll 15 patients to analyze sirolimus levels in blood during the first week after implantation. Clinical follow-up visits are scheduled at 1, 6, 12, 36, and 60 months post-procedure. Participants will undergo assessments throughout the study including clinical evaluations and monitoring for safety and device performance. The primary outcome is the percentage of patients experiencing Target Lesion Failure at 12 months. Follow-up will continue for five years to observe long-term outcomes. The total study duration is about six and a half years, including recruitment and follow-up periods.
CONDITIONS
Brief Title
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Written informed consent provided before study procedures
- Eligible for percutaneous coronary intervention (PCI) per guidelines
- Acceptable candidate for coronary artery bypass surgery
- Stable or unstable angina, silent ischemia, or stable non-ST elevation myocardial infarction (NSTEMI) without thrombus at target lesion
- STEMI patients eligible only for non-culprit lesions if stable and consent given at least 72 hours after culprit lesion treatment
- Eligible for dual antiplatelet therapy (aspirin plus clopidogrel, prasugrel, ticagrelor, cangrelor, or ticlopidine)
- Left ventricular ejection fraction (LVEF) 30% or higher within 6 months prior or during procedure
- Willing and able to comply with study protocol and visits
- Up to two single de novo target lesions in separate native coronary arteries
- Target vessel diameter between 2.7 and 4.2 mm
- Target lesion length between more than 28 mm and up to 38 mm treatable with one device
- Target lesion stenosis 50% or more and less than 100%, with clinical justification if less than 70%
- Target lesion with TIMI flow grade 1 or higher
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during study
- STEMI symptoms or ECG changes within 72 hours before procedure
- Prior PCI in target vessel within 12 months or non-target vessel within 72 hours before procedure
- On dialysis or impaired renal function (serum creatinine above 2.5 mg/dL within 72 hours prior)
- Allergy to contrast medium, aspirin, P2Y12 inhibitors, heparin, bivalirudin, sirolimus, or scaffold materials
- Receiving oral or intravenous immunosuppressive therapy or life-limiting autoimmune disease
- Life expectancy less than 1 year
- Planned surgery or dental surgery within 6 months unless dual antiplatelet therapy can continue
- Unable to comply with follow-up
- On oral anticoagulation therapy unless triple therapy with dual antiplatelet therapy can be maintained for at least 1 month
- Stroke or transient ischemic attack within 6 months prior
- Active bleeding disorders or coagulopathies
- Currently participating or planning other investigational drug or device studies
- Target vessel previously treated near the lesion
- Left main coronary artery disease
- Totally occluded target lesion
- Thrombus in target vessel
- Planned staged PCI in target or non-target vessels
- Ostial lesions near vessel origins
- Lesions involving large side branches requiring two devices
- Lesions in arterial or venous bypass grafts
- Excessive vessel tortuosity or calcification preventing adequate pre-dilation
- Need for device other than balloons before scaffold placement
- Prior brachytherapy in target vessel
- Unsuccessful pre-dilation or angiographic complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants with symptomatic coronary artery disease will undergo implantation of a sirolimus-eluting resorbable coronary magnesium scaffold (Freesolve 35- or 40-mm scaffold) to treat long de novo lesions in native coronary arteries.
1 procedure visit (in-person)
Duration - Up to 60 months
Participants will be followed for clinical performance and safety assessments after the scaffold implantation.
Visits at 1, 6, 12, 36, and 60 months post-procedure
Trial Site Locations
Total: 8 locations
1
Katholisches Krankenhaus "St. Johann Nepomuk"
Erfurt, Germany, 99097
Actively Recruiting
2
Universitätsklinikum Halle (Saale)
Halle, Germany, 6120
Actively Recruiting
3
Klinikverbund Allgäu gGmbH
Immenstadt and Kempten, Germany, 87509
Actively Recruiting
4
Centro Cardiologico Monzino SpA
Milan, Italy, 20138
Actively Recruiting
5
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy, 37126
Not Yet Recruiting
6
Pauls Stradins Clinical University Hospital
Riga, Latvia, 1002
Actively Recruiting
7
Miedziowe Centrum Zdrowia S.A
Lubin, Poland, 59-311
Actively Recruiting
8
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
Research Team
B
Barbara Widmann, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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