Safety and clinical performance of the magnesium-based bioresorbable coronary stent (Freesolve) in the treatment of patients with lesions in the coronary arteries: BIOMAG-II
Summary description of the study
The objective of the study is to evaluate the safety and efficacy of the bioresorbable Freesolve stent from BIOTRONIK in the treatment of patients with up to two stenoses of the coronary arteries, compared to the Abbott Xience stent, which is made of a permanent material. This is an international, multicenter clinical trial to compare the Freesolve stent with the Xience stent regarding the target lesion failure (TLF) rate at 12 months. TLF is a composite rate of cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR) rate. Patients will be randomly implanted either with the bioresorbable Freesolve stent (intervention group) or with the permanent Xience stent (control group) and will be followed up to 5 years after the intervention.
(BASEC)
Intervention under investigation
The common name for the intervention is percutaneous transluminal coronary angioplasty (PTCA). During this procedure under local anesthesia, a catheter will be placed inside the groin or arm to access an artery. A bioresorbable Freesolve stent or a Xience stent will be implanted in the coronary artery requiring treatment. The correct positioning is monitored by angiography, and a balloon is inflated to open the prosthesis and press it against the vessel wall. Then, the deflated balloon is removed from the vessel, and the prosthesis remains in place. The procedure for implanting the bioresorbable Freesolve stent is the same as for the Xience stent. Depending on the usual treatment process of the study physician, the entire procedure will last between 30 and 60 minutes.
(BASEC)
Disease under investigation
Stenosis of the coronary arteries (heart blood vessels)
(BASEC)
- The subject is eligible for the percutaneous transluminal coronary angioplasty (PTCA) intervention. - The subject is an acceptable candidate for aortocoronary bypass surgery. - The subject is eligible for dual antiplatelet therapy (DAPT). (BASEC)
Exclusion criteria
- The subject presents clinical symptoms and/or electrocardiogram (ECG) changes compatible with a "STEMI" myocardial infarction within 72 hours prior to the study procedure. - The subject has undergone PTCA in the target vessel within the last 12 months prior to the study procedure, or PTCA in another vessel within 72 hours prior to the study procedure. - The subject is on dialysis or has renal insufficiency. (BASEC)
Trial sites
Basel, Bern, Freiburg, Geneva, Lugano, Zurich
(BASEC)
Sponsor
BIOTRONIK AG
(BASEC)
Contact
Contact Person Switzerland
Dimitra Antonopoulou
+41 75 429 5753
dimitra.antonopoulou@clutterbiotronik.comBIOTRONIK AG
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Geneva
(BASEC)
Date of authorisation
07.05.2024
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
BIOMAG-II (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
not available
Secondary sponsors
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Additional contacts
not available
Secondary trial IDs
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Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
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Link to the results in the primary register
not available