Actively Recruiting
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions
Led by Biotronik AG · Updated on 2025-11-21
100
Participants Needed
8
Research Sites
327 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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...
- Be between 18 and 80 years old
- Provide written informed consent approved by an ethics committee or institutional review board
- Be eligible for percutaneous coronary intervention (PCI) according to guidelines
- Be an acceptable candidate for coronary artery bypass surgery
- Have stable or unstable angina, silent ischemia, or stable non-ST elevation myocardial infarction without thrombus at target lesion
- STEMI patients may be eligible for treatment of non-culprit lesions if stable and meeting all criteria
- Be eligible for dual antiplatelet therapy with aspirin plus another antiplatelet drug
- Have a left ventricular ejection fraction of at least 30% within 6 months prior to the procedure
- Be willing and able to comply with study requirements and visits
- Have up to two single new target lesions in separate native coronary arteries
- Target vessel diameter between 2.7 and 4.2 mm
- Target lesion length between greater than 28 mm and up to 38 mm suitable for single device treatment
- Target lesion stenosis of at least 50% but less than 100%, with clinical justification if less than 70%
- Target lesion must have a Thrombolysis In Myocardial Infarction (TIMI) flow grade of 1 or higher
You will not qualify if you...
- Be pregnant, breastfeeding, or planning pregnancy during the study
- Have symptoms or ECG changes of STEMI less than 72 hours before the procedure
- Had prior PCI in the target vessel within 12 months or non-target vessel within 72 hours
- Be on dialysis or have impaired kidney function with serum creatinine over 2.5 mg/dL
- Have allergy to contrast medium, aspirin, P2Y12 inhibitors, heparin, bivalirudin, sirolimus, or scaffold materials
- Be receiving oral or intravenous immunosuppressive therapy or have life-limiting autoimmune disease
- Have life expectancy less than 1 year
- Have planned surgery or dental surgery within 6 months unless dual antiplatelet therapy can be maintained
- Be unable to comply with follow-up visits
- Be on oral anticoagulation therapy unless triple therapy can be maintained for at least 1 month
- Had a stroke or transient ischemic attack in the past 6 months
- Have an active bleeding disorder or be ineligible for dual antiplatelet therapy
- Currently participating or planning to participate in another investigational study
- Target vessel previously treated lesion within 5 mm
- Have left main coronary artery disease
- Have a totally occluded target lesion (100% stenosis)
- Presence of thrombus in the target vessel
- Planned staged PCI in target or non-target vessels
- Ostial target lesion within 5 mm of vessel origin in major arteries
- Target lesion involving a side branch requiring two-device strategy
- Target lesion in or supplied by a bypass graft
- Excessive vessel tortuosity or heavy calcification preventing proper lesion preparation
- Need for treatment with devices other than specified balloons before scaffold placement
- Prior brachytherapy in target vessel
- Unsuccessful lesion pre-dilatation or angiographic complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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