Actively Recruiting
BIOTRONIK - Safety and Clinical Performance of the Drug Eluting Resorbable Coronary Magnesium Scaffold System (Freesolve) in Treating Subjects With de Novo Lesions in Native Coronary Arteries
Led by Biotronik AG · Updated on 2025-11-21
1859
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the BIOTRONIK Sirolimus Eluting Resorbable Magnesium Scaffold System (Freesolve RMS) compared to the Xience Everolimus Eluting Stent System (Xience DES) in treating patients with up to two new lesions in their native coronary arteries. This international, randomized controlled trial aims to measure the rate of target lesion failure within 12 months after the procedure, involving a total of 1859 participants across Europe and Asia-Pacific regions. Participants will be randomly assigned in a 2:1 ratio to receive either the Freesolve RMS or the Xience DES device. The treatment involves implanting one of these devices into the affected coronary arteries during a percutaneous coronary intervention (PCI). Follow-up visits are scheduled at 1, 6, and 12 months after the procedure, with additional check-ups at 2, 3, 4, and 5 years to monitor long-term outcomes. During the study, participants will have clinical evaluations at these visits to track the success and safety of their assigned device. Researchers will assess the primary outcome of target lesion failure at 12 months, which includes complications related to the treated artery. Participants will be monitored for up to five years to gather extended safety and performance data, and they are expected to follow the study protocol including medication and scheduled visits throughout this period.
CONDITIONS
Brief Title
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Provided written informed consent before any study procedures
- Eligible for percutaneous coronary intervention (PCI) per guidelines
- Suitable candidate for coronary artery bypass surgery
- Diagnosed with stable or unstable angina, silent ischemia, abnormal physiological testing, or stable NSTEMI without thrombus at target lesion
- STEMI patients may be eligible for selected non-culprit lesions if stable and meet criteria
- Eligible for dual antiplatelet therapy (aspirin plus clopidogrel, prasugrel, ticagrelor, or ticlopidine)
- Left ventricular ejection fraction (LVEF) ≥ 30% within 6 months before or during procedure
- Willing and able to comply with protocol and complete study visits
- Up to two single new target lesions in separate native coronary arteries
- Target vessel diameter between 2.5 and 4.2 mm
- Target lesion length ≤ 28 mm (or < 20 mm for lesions < 3.0 mm diameter)
- Target lesion stenosis ≥ 50% and < 100%, with clinical justification if < 70%
- Target lesion has TIMI flow grade ≥ 1
You will not qualify if you...
- Pregnant or 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 PCI within 72 hours before procedure
- On dialysis or impaired renal function (serum creatinine > 2.5 mg/dL)
- Allergic to contrast medium, aspirin, P2Y12 inhibitors, heparin, bivalirudin, sirolimus, everolimus, scaffold or stent materials
- Receiving immunosuppressive therapy or has life-limiting immunosuppressive or autoimmune disease (except diabetes)
- Life expectancy less than 1 year
- Planned surgery or dental surgery within 6 months unless dual antiplatelet therapy can be maintained
- Unable to comply with follow-up
- On oral anticoagulation unless triple therapy can be maintained for at least 1 month
- Had stroke or transient ischemic attack within 6 months
- Active bleeding disorder or coagulopathy
- Participating or planning to participate in another investigational study
- Target vessel previously treated within 5 mm of lesion
- Left main coronary artery disease
- Totally occluded target lesion (100% stenosis)
- Thrombus in target vessel
- Planned staged PCI in target or non-target vessels
- Ostial lesion within 5 mm of vessel origin
- Lesion involving side branch ≥ 2.0 mm requiring two-device strategy
- Lesion located in or supplied by bypass graft
- Excessive tortuosity or heavy calcification preventing adequate pre-dilation
- Requires treatment other than non-compliant or cutting/scoring balloon prior to device placement
- Prior brachytherapy in target vessel
- Unsuccessful pre-dilation with residual stenosis > 20% 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.
screening and enrollment visit
Duration - Day of procedure
Participants undergo implantation of either the Freesolve Resorbable Magnesium Scaffold System or the Xience Everolimus Eluting Stent System.
1 procedure visit (in-person)
Duration - Up to 5 years
Participants are followed clinically to assess safety and performance of the implanted device.
Clinical follow-up visits at 1, 6, 12 months and at 2, 3, 4, and 5 years post-procedure
Trial Site Locations
Total: 1 location
1
Rheinland Klinikum Neuss GmbH Lukaskrankenhaus Neuss
Neuss, Germany, 41464
Actively Recruiting
Research Team
B
Barbara Widmann, PhD
N
Nadine Kluser
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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