A clinical study by BIOTRONIK to collect data on the safety and efficacy of the 48-mm long drug-eluting Orsiro Mission Stent for the treatment of patients with stenoses in blood vessels in the heart: BIOFLOW-48
Summary description of the study
The aim of the study is to collect data on the safety and efficacy of the 48-mm long Orsiro Mission stent. This stent can treat stenotic lesions ranging from 37 mm to 44 mm in length. The international, multicenter clinical study will be conducted at approximately 35 study centers in Europe and the USA, with up to 150 patients to be included. The outcome of the study will be evaluated based on the target lesion failure (TLF) rate after 12 months. TLF is a rate that consists of cardiac death, myocardial infarction (MI) at the treated target vessel (TV), and the target lesion revascularization (TLR) rate.
(BASEC)
Intervention under investigation
Use of the 48-mm long drug-eluting Orsiro Mission Stent in the narrowed section of the coronary artery responsible for the patient's complaints.
(BASEC)
Disease under investigation
The coronary arteries (blood vessels in the heart) have a narrowing that may need to be treated. This narrowing can be caused by deposits on the walls of the arteries (atherosclerosis). As a result, the heart is not sufficiently supplied with oxygen and nutrients, which impairs heart function. This disorder is referred to as stenosis of the coronary arteries and can be the cause of clinical symptoms.
(BASEC)
1. Individuals aged >18 years. 2. Written informed consent from the patient. 3. Subjects with a maximum of two lesions in two different coronary arteries, with only one to be treated with the investigational product. (BASEC)
Exclusion criteria
1. Pregnant or breastfeeding women or women intending to become pregnant during the study. 2. PCI in the target vessel within the last 12 months or PCI in a non-target vessel within the last 72 hours. 3. Target lesion is a complete occlusion. (BASEC)
Trial sites
Basel
(BASEC)
Sponsor
BIOTRONIK AG, Bülach CHE
(BASEC)
Contact
Contact Person Switzerland
Doris Lang
+41 75 429 5456
doris.lang@clutterbiotronik.comBIOTONIK AG
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
17.03.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
BIOTRONIK – A Prospective Multicenter Single-Arm Study to Assess the Safety and Effectiveness of the Orsiro Mission 48- mm Sirolimus-Eluting Coronary Stent System for the Treatment of Subjects with Atherosclerotic Lesion(s): BIOFLOW-48 (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
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
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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
not available
Link to the results in the primary register
not available