Actively Recruiting
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System
Led by Biotronik AG · Updated on 2025-11-21
1859
Participants Needed
1
Research Sites
402 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this study is to assess the safety and efficacy of the Freesolve in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to a contemporary drug eluting stent (DES).
CONDITIONS
Official 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 study procedures
- Eligible for percutaneous coronary intervention (PCI) as per guidelines
- Suitable candidate for coronary artery bypass surgery
- Have stable or unstable angina, documented silent ischemia, abnormal physiologic testing, or stable non-ST elevation myocardial infarction (NSTEMI) without thrombus at target lesion
- For STEMI patients: target lesion is non-culprit, meet all inclusion criteria, consent at least 72 hours after culprit lesion treatment, hemodynamically stable with declining cardiac biomarkers
- Eligible for dual antiplatelet therapy (aspirin plus clopidogrel, prasugrel, ticagrelor, or ticlopidine)
- Left ventricular ejection fraction (LVEF) of 30% or higher within 6 months before or during the procedure
- Willing and able to comply with study protocol and complete all visits
- Have 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 less (or less than 20 mm if vessel diameter is under 3.0 mm) amenable to treatment with a single device
- Target lesion stenosis between 50% 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 the study
- Clinical symptoms or ECG changes of STEMI within 72 hours before the procedure
- Prior PCI in target vessel within 12 months or in non-target vessel within 72 hours before procedure (unless uncomplicated and successful)
- On dialysis or impaired kidney function (serum creatinine over 2.5 mg/dL within 72 hours before procedure)
- Known allergy to contrast medium, aspirin, P2Y12 inhibitors, heparin, bivalirudin, sirolimus, everolimus, scaffold materials, or stent materials
- Receiving oral or intravenous immunosuppressive therapy (except inhaled steroids) or have life-limiting immunosuppressive or autoimmune disease
- Life expectancy less than 1 year
- Planned surgery or dental surgery within 6 months after procedure unless dual antiplatelet therapy can continue
- Unable to comply with follow-up requirements
- On oral anticoagulation therapy before procedure unless triple therapy can be maintained for at least 1 month
- Stroke or transient ischemic attack within 6 months before procedure
- Active bleeding disorder or coagulopathy making dual antiplatelet therapy unsafe
- Currently participating or planning to participate in another investigational study
- Target vessel previously treated with lesion within 5 mm proximal or distal
- Left main coronary artery disease
- Totally occluded target lesion (100% stenosis)
- Presence of thrombus in target vessel
- Planned staged PCI in target or non-target vessel
- Ostial target lesion within 5 mm of vessel origin in major coronary arteries
- Target lesion involving side branch requiring two-device strategy after pre-dilatation
- Target lesion in or supplied by arterial or venous bypass graft
- Excessive tortuosity or heavy calcification preventing adequate pre-dilatation
- Need for treatment other than non-compliant or cutting/scoring balloon before scaffold/stent placement
- Target vessel previously treated with brachytherapy
- Unsuccessful pre-dilatation with residual stenosis over 20% or angiographic complications
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Rheinland Klinikum Neuss GmbH Lukaskrankenhaus Neuss
Neuss, Germany, 41464
Actively Recruiting
Research Team
B
Barbara Widmann, PhD
CONTACT
N
Nadine Kluser
CONTACT
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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