The Biomimetic Stent and Vascular Functions Study

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05447052
• Other study ID #: The MIMICS FLOW STUDY
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2021
• Est. completion date: April 26, 2025

Study information

• Verified date: December 2023
• Source: University Hospital, Essen
• Contact: Christos Rammos, Professor
• Phone: 0201-723-84808
• Email: christos.rammos[@]uk-essen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 26, 2025
• Est. primary completion date: April 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Bio-MIMICS 3D Stent
Bio-MIMICS Stent implantation
• Innova Stent
Innova Stent implantation

Locations

Country	Name	City	State
Germany	University of Essen, Clinic of Cardiology and Angiology	Essen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Changes in pulse wave velocity	Changes in cardiovascular function measured by pulse wave velocity in m/s	Baseline, followed at 1 and 12 months
Secondary	Changes in augmentation index	Changes in cardiovascular function measured by augmentation index in %	Baseline, followed at 1 and 12 months
Secondary	Changes in vascular strain	Changes in cardiovascular function measured by vascular strain in %	Baseline, followed at 1 and 12 months
Secondary	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
Secondary	Primary patency (PP) of target lesion	Primary patency determined by PVR measurement with ultrasound	Baseline, followed at 1 and 12 months
Secondary	Changes in clinical symptoms	Clinical symptoms of patients determined by Walking impairment questionaire (WIQ)	Baseline, followed at 1 and 12 months
Secondary	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
Secondary	Freedom from Target Lesion Revascularization	Freedom from Target Lesion Revascularization (FTLR)	Baseline, followed at 1 and 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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