Clinical trial NCT05447052: The Biomimetic Stent and Vascular Functions Study
Official title: The Biomimetic Stent and Vascular Functions Study-The MIMICS FLOW STUDY
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this IIT is to determine the potential improvement and impact of the BioMimics 3D Stent System in the SFA on local vascular function.

Detailed description: The MIMICS FLOW Study is a single-center, single-blind, investigator-initiated, randomized parallel group trial.

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.

Eligibility 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

Primary outcomes:
measure: Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure
timeFrame: 1 month
measure: Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure
timeFrame: 12 months
Secondary outcomes:
measure: Changes in pulse wave velocity
timeFrame: Baseline, followed at 1 and 12 months
measure: Changes in augmentation index
timeFrame: Baseline, followed at 1 and 12 months
measure: Changes in vascular strain
timeFrame: Baseline, followed at 1 and 12 months
measure: Changes in peripheral perfusion determined by ABI (ankle brachial index)
timeFrame: Baseline, followed at 1 and 12 months
measure: Primary patency (PP) of target lesion
timeFrame: Baseline, followed at 1 and 12 months
measure: Changes in clinical symptoms
timeFrame: Baseline, followed at 1 and 12 months
measure: Changes in six-minute walk test
timeFrame: Baseline, followed at 1 and 12 months
measure: Freedom from Target Lesion Revascularization
timeFrame: Baseline, followed at 1 and 12 months
measure: Number of participants with treatment-related adverse events
timeFrame: Baseline, followed at 1 and 12 months
measure: Changes of inflammatory profile measured by hs-CRP in mg/dl
timeFrame: Baseline, followed at 1 and 12 months
measure: Changes of inflammatory profile measured by oxLDL in µg/l
timeFrame: Baseline, followed at 1 and 12 months
measure: Changes of inflammatory profile measured by Interleukin-6 in pg/ml
timeFrame: Baseline, followed at 1 and 12 months
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University of Essen, Clinic of Cardiology and Angiology
state: NRW
Study officials:
affiliation: University Hospital, Essen
name: Christos Rammos, Professor
role: PRINCIPAL_INVESTIGATOR
References: