The Biomimetic Stent and Vascular Functions Study

NCT05447052 | Unknown FDA Device

• 1 other identifier: The MIMICS FLOW STUDY
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Changes in pulse wave velocity

  Baseline, followed at 1 and 12 months

• Changes in augmentation index

  Baseline, followed at 1 and 12 months

• Changes in vascular strain

  Baseline, followed at 1 and 12 months

• Changes in peripheral perfusion determined by ABI (ankle brachial index)

  Baseline, followed at 1 and 12 months

• Primary patency (PP) of target lesion

  Baseline, followed at 1 and 12 months

Study Arms (2)

Bio-MIMICS Stent

EXPERIMENTAL

Helical shaped BioMimics 3D Stent

Device: Bio-MIMICS 3D Stent

Innova Stent

ACTIVE COMPARATOR

Conventional: Nitinol Stent

Device: Innova Stent

Interventions

Bio-MIMICS 3D Stent DEVICE

Bio-MIMICS Stent implantation

Bio-MIMICS Stent

Innova Stent DEVICE

Innova Stent implantation

Innova Stent

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Essen: lead

Study Sites (1)

University of Essen, Clinic of Cardiology and Angiology

Essen, North Rhine-Westphalia, 45147, Germany

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Christos Rammos, Professor

  University Hospital, Essen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christos Rammos, Professor

CONTACT

0201-723-84808; christos.rammos@uk-essen.de

Tienush Rassaf, Professor

CONTACT

0201-723-4801; tienush.rassaf@uk-essen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. C. Rammos, MD, FESC, MHBA

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: July 7, 2022
• Study Start: April 26, 2021
• Primary Completion: April 26, 2024
• Study Completion: April 26, 2025
• Last Updated: December 5, 2023

Record last verified: 2023-12

Locations

DE (1)