Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
70 participants
INTERVENTIONAL
2021-04-26
2025-04-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The impact of a novel biomimetical stent with a helical curvature provides superior hemodynamic and biomechanical performance and advantages. Additionally, it promotes swirling blood flow, elevating wall sheer strength, which is patency-protective and might impact on vascular functions due to completely different vascular properties through altered blood flow.
The influence of the novel devices and stent-platforms with improved hemodynamic capabilities with respect to vasomotor of the vessel wall, vascular function and vascular compliance can be measured by FMD, arterial stiffness indices and vascular strain analysis.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Bio-MIMICS Stent
Helical shaped BioMimics 3D Stent
Bio-MIMICS 3D Stent
Bio-MIMICS Stent implantation
Innova Stent
Conventional: Nitinol Stent
Innova Stent
Innova Stent implantation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bio-MIMICS 3D Stent
Bio-MIMICS Stent implantation
Innova Stent
Innova Stent implantation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Target lesions in the proximal (3 cm distal to the CFA-bifurcation) middle and distal SFA
* Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Rutherford 2,3,4
* Planed peripheral intervention TASC A-D
* Subject must be between 18 and 85 years old
* Female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12 month angiographic evaluation
* Vessel diameter \>/= 4.0 mm and \</=7.0 mm
* Target lesion length \< 140 mm (segment to be stented)
* Willing to comply with the specified follow-up evaluation
* Written informed consent prior to any study procedures
* Pretreatment with an adequately sized ballon (1:1 ration to nonstenotic vessel diameter)
* usage of Biomimics stent as described in the IFU, especially regarding stent diameters and vessel size
Exclusion Criteria
* Requiring stent implantation in the PA
* Instent-Restenosis
* Thrombolysis within 72 Hours prior to the index procedure
* Aneurysm formations in the femoral artery or popliteal artery
* Concomitant hepatic insufficiency, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy
* Unstable angina pectoris at the time of the enrollment
* Recent myocardial infarction or stroke \<30 days prior to the index procedure
* Life expectancy less than 12 months
* Septicaemia at the time of enrollment
* Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound of the target limb
* Known or suspected allergies or contraindications to aspirin, clopidogrel or heparin
* Presence of other hemodynamically significant outflow lesions in the target limb requiring a planned surgical intervention or endovascular procedure within 30 days after the index procedure
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Essen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Chistos Rammos
Prof. Dr. med. C. Rammos, MD, FESC, MHBA
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christos Rammos, Professor
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Essen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Essen, Clinic of Cardiology and Angiology
Essen, North Rhine-Westphalia, Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Christos Rammos, Prof.
Role: primary
Tienush Rassaf, Univ.-Prof.
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
The MIMICS FLOW STUDY
Identifier Type: -
Identifier Source: org_study_id