The Biomimetic Stent and Vascular Functions Study

The Biomimetic Stent and Vascular Functions Study-The MIMICS FLOW STUDY

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Bio-MIMICS 3D Stent; Device: Innova Stent

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christos Rammos, Professor; Phone Number: 0201-723-84808; Email: christos.rammos@uk-essen.de
• Study Contact Backup: Name: Tienush Rassaf, Professor; Phone Number: 0201-723-4801; Email: tienush.rassaf@uk-essen.de

Study Locations

• Germany
  • NRW
    • Essen, NRW, Germany, 45147
      • Recruiting
      • University of Essen, Clinic of Cardiology and Angiology
      • Contact: Christos Rammos, Prof.; Phone Number: +4920172384808; Email: christos.rammos@uk-essen.de
      • Contact: Tienush Rassaf, Univ.-Prof.; Phone Number: +492017234801; Email: tienush.rassaf@uk-essen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bio-MIMICS Stent; Helical shaped BioMimics 3D Stent	Device: Bio-MIMICS 3D Stent; Bio-MIMICS Stent implantation
Active Comparator: Innova Stent; Conventional: Nitinol Stent	Device: Innova Stent; Innova Stent implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure	FMD represents the percent diameter gain as calculated based on preischemia and postischemia diameter measurements of the femoral artery.	1 month
Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure	FMD represents the percent diameter gain as calculated based on preischemia and postischemia diameter measurements of the femoral artery.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in pulse wave velocity	Changes in cardiovascular function measured by pulse wave velocity in m/s	Baseline, followed at 1 and 12 months
Changes in augmentation index	Changes in cardiovascular function measured by augmentation index in %	Baseline, followed at 1 and 12 months
Changes in vascular strain	Changes in cardiovascular function measured by vascular strain in %	Baseline, followed at 1 and 12 months
Changes in peripheral perfusion determined by ABI (ankle brachial index)	ABI measurements are conducted using a Doppler probe on tibial and anterior artery locations. The highest value will be used for calculation and divided by the highest systolic brachial Doppler pressure	Baseline, followed at 1 and 12 months
Primary patency (PP) of target lesion	Primary patency determined by PVR measurement with ultrasound	Baseline, followed at 1 and 12 months
Changes in clinical symptoms	Clinical symptoms of patients determined by Walking impairment questionaire (WIQ)	Baseline, followed at 1 and 12 months
Changes in six-minute walk test	Six-minute walk test determined by pain-free walking distance in m	Baseline, followed at 1 and 12 months
Freedom from Target Lesion Revascularization	Freedom from Target Lesion Revascularization (FTLR)	Baseline, followed at 1 and 12 months
Number of participants with treatment-related adverse events	Number of participants with treatment-related adverse events as assessed by SDWS	Baseline, followed at 1 and 12 months
Changes of inflammatory profile measured by hs-CRP in mg/dl	Blood samples are collected at the below mentioned time points	Baseline, followed at 1 and 12 months
Changes of inflammatory profile measured by oxLDL in µg/l	Blood samples are collected at the below mentioned time points	Baseline, followed at 1 and 12 months
Changes of inflammatory profile measured by Interleukin-6 in pg/ml	Blood samples are collected at the below mentioned time points	Baseline, followed at 1 and 12 months

Collaborators and Investigators

• Sponsor: University Hospital, Essen
• Investigators: Principal Investigator: Christos Rammos, Professor, University Hospital, Essen

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2021
• Primary Completion (Estimated): April 26, 2024
• Study Completion (Estimated): April 26, 2025

Study Registration Dates

• First Submitted: June 2, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 2, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: The MIMICS FLOW STUDY

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes