Evaluating a new stent for improving blood flow in peripheral artery disease
The Biomimetic Stent and Vascular Functions Study-The MIMICS FLOW STUDY
This study is testing a new type of stent to see if it can improve blood flow and vascular health in people with peripheral artery disease compared to traditional stents.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital, Essen Academic / other |
| Locations | 1 site (Essen, NRW) |
| Trial ID | NCT05447052 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of the BioMimics 3D Stent System in enhancing local vascular function in patients with peripheral arterial disease. It is a single-center, single-blind, randomized trial that compares the novel biomimetic stent with traditional stents. The study will measure various vascular parameters, including blood flow dynamics and vessel wall compliance, to determine the stent's impact on vascular health. Participants will undergo a planned peripheral intervention and will be monitored for 12 months post-procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with symptomatic lower limb ischemia due to peripheral artery disease affecting specific segments of the superficial femoral artery.
Not a fit: Patients with bifurcational lesions of the common femoral artery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with peripheral arterial disease, enhancing their vascular function and overall health.
How similar studies have performed: Other studies have shown promising results with similar biomimetic approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Peripheral artery disease * 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: * Bifurcational lesions of the CFA and lesions including the first 3 cm of the SFA, due to technical aspects of FMD measurement * 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
Where this trial is running
Essen, NRW
- University of Essen, Clinic of Cardiology and Angiology — Essen, Nrw, Germany (Recruiting)
Study contacts
- Principal investigator: Christos Rammos, Professor — University Hospital, Essen
- Study coordinator: Christos Rammos, Professor
- Email: christos.rammos@uk-essen.de
- Phone: 0201-723-84808
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.