Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D (MIMICS-3D)

A Prospective, Multicentre Observational Study to Evaluate the BioMimics 3D Self-Expanding Stent System in the Treatment of Peripheral Arterial Disease: MIMICS-3D

The MIMICS-3D study will evaluate safety, effectiveness and device performance within a real-world clinical population of patients undergoing femoropopliteal intervention.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: BioMimics 3D Stent

Detailed Description

The MIMICS-3D study is a prospective, multicentre, observational study of the BioMimics 3D Stent System in patients undergoing endovascular intervention to relieve symptomatic peripheral arterial disease of the femoropopliteal artery. The study is designed to enable the collection, analysis and reporting of data from "real-world" use of the BioMimics 3D Stent System used in accordance with the Instructions for Use (IFU) associated with the product's CE Mark approval.

Data collection will include that relating to safety, effectiveness and device performance and the period of observation during which data will be collected will extend from the index procedure through 3 years (36 months), according to the standard follow-up practice of the enrolling institution.

• Study Type: Observational
• Enrollment (Actual): 507

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium
    • OLV Hospital
  • Antwerp, Belgium
    • ZNA Vascular Clinic/ZNA Stuivenburg Hospital
  • Dendermonde, Belgium
    • AZ Sint Blasius
  • Gent, Belgium
    • AZ Maria Middelares
  • Tienen, Belgium
    • Regionaal Vaartcentrum , AZ Helig Hart Tienen
• Germany
  • Arnsberg, Germany
    • Karolinen-Hospital
  • Bad Krozingen, Germany
    • Universitaets-Herzzentrum Freiburg-Bad Krozingen
  • Berlin, Germany
    • KEH Berlin
  • Berlin, Germany
    • Vivantes Klinikum Friedrichshain
  • Buchholz, Germany
    • Krankenhaus Buchholz
  • Dresden, Germany, 01067
    • Krankenhaus Dresden-Friedrichstadt, Städtisches Klinikum
  • Essen, Germany
    • Universitatsklinikum Essen
  • Frankfurt am Main, Germany, 60389
    • CCB im Agaplesion Bethanien Krankenhaus
  • Hamburg, Germany, 21075
    • Asklepios Klinik Harburg
  • Hamburg, Germany
    • UKE (University Hospital Hamburg)
  • Leipzig, Germany
    • Universitätsklinikum Leipzig AöR
  • Munich, Germany
    • Gefäßpraxis im Tal
  • Osnabruck, Germany
    • Marienhospital Osnabrück GmbH
  • Rosenheim, Germany, 83022
    • RoMed Klinikum Rosenheim
  • Suhl, Germany, 98527
    • SRH-Klinikum Zentralklinikum Suhl
  • Tübingen, Germany, 72016
    • Universitatsklinikum Tubingen
• Netherlands
  • Arnhem, Netherlands
    • Rijnstate Hospital
• Sweden
  • Malmö, Sweden
    • Skane University Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients who receive treatment with Veryan's BioMimics 3D Stent System in accordance with the current approved CE Mark indication for use as stated in the Instructions for Use (IFU) will be consecutively enroled in this study.

Description

Inclusion Criteria:

• Patient is age ≥18 and ≤85 years at date of consent.
• Patient has provided written informed consent for participation in the study prior to index procedure.
• Patient has documented symptomatic peripheral arterial disease scheduled for treatment with the BioMimics 3D stent in accordance with the approved CE Mark indication and Instructions for Use (IFU)

Exclusion Criteria:

• Patients whose lesions cannot be crossed with a wire and/or balloon catheter and cannot be dilated sufficiently to allow passage of the delivery system.
• Patients with a history of intolerance or adverse reaction to antiplatelet and/or anticoagulation therapies, bleeding diathesis, severe hypertension or renal failure.
• Patients with known hypersensitivity to nickel-titanium.
• Patient has a comorbidity that in the Investigator's opinion would limit life expectancy to less than 12 months.
• Patient is pregnant or breastfeeding.
• Patient is unable or is unwilling to comply with site standard of care procedures and follow-up visit schedules for patients undergoing femoropopliteal intervention.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Free From Major Adverse Events (MAE)	Primary Safety Endpoint: Number of participants free from a composite of major adverse events (MAE) comprising death, any major amputation performed on the index limb or clinically-driven target lesion revascularization (CDTLR) through 30 days.	30 days
Number of Participants Free From Clinically-driven Target Lesion Revascularization (CDTLR)	Primary Effectiveness Endpoint: Number of participants free from clinically-driven target lesion revascularization (CDTLR) through 12 months.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a Final Residual Diameter Stenosis ≤30% at the End of the Index Procedure	Acute Technical Success: Number of participants with a final residual diameter stenosis ≤30% within 72 hours of the index procedure.	Within 72 hours of the index procedure.
Number of Participants With Acute Technical Success and Absence of the Adverse Events Listed in the Description	Acute Procedural Success: Number of participants with acute technical success (achievement of a final stenosis ≤30% at the end of the procedure) and absence of the following adverse events: death, stroke, myocardial infarction, acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and/or need for urgent/emergent vascular surgery, within 72 hours of index procedure.	Within 72 hours of index procedure.
Percent Probability of Individual Components of MAE	A Kaplan-Meier (KM) analysis of individual components of MAE (death, any major amputation performed on the index limb or CDTLR) through 24 months.	30 days, 12 Months, and 24 Months.
Number of Participants With Adverse Events	Overall rate of all adverse events reported from Day 0 through 24 months. An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in participants, whether or not related to the investigational device or procedure. For the purpose of this Study all potentially device-related and procedure-related adverse events, major adverse events (death, major amputation on the target limb, clinically-driven target lesion revascularisation), all vascular adverse events in the target limb, and serious adverse events are reported throughout the Study.	30 day, 12 and 24 months
Stent Patency Rate	Per Protocol, patency is defined as the composite of freedom from more than 50% restenosis within the stented segment as observed by Duplex Ultrasound or Angiography within the visit window and freedom from clinically-driven target lesion revascularisation prior to the indicated time point. Stent patency rate assessed by duplex ultrasound (DUS), as available, determined at Months 12 and 24. This will be assessed using values of peak systolic velocity ratio (PSVR) >2.0, >2.4; >2.5; and >3.5. PSVR values of >2.0, >2.4, >2.5 and >3.5 were selected to compare outcomes from similar studies. There are no official definitions or guidelines on these values and which are most accurate for detection of >50% stenosis, so all have been used in the analyses to compare results from other studies. PSVR of >2.4, was looked at further as there are some studies that state this is the most established threshold for the detection of >50% stenosis (Schlager, et al. 2007).	12 and 24 months.
Comparison of Rutherford Clinical Category	Clinical Outcome: Comparison of Rutherford Clinical Category (RCC) measured at Baseline, Day 30, Months 12 and 24. Rutherford Clinical Category is a clinical scale identifying three grades of claudication (RCC 1-3) and three grades of critical limb ischemia (RCC 4-6) ranging from rest pain alone to minor and major tissue loss. Category and clinical description: 0 - Asymptomatic, 1 - Mild claudication 2 - Moderate claudication, 3 - Severe claudication, 4 - Ischemic rest pain, 5 - Minor tissue loss, 6 - Ulceration or gangrene.	Baseline, Day 30, 12 months and 24 months
Comparison of Ankle Brachial Index (ABI) Measurement	Functional outcome: Mean and standard deviation of the Ankle Brachial Index at each follow-up visit is reported. The change of Ankle Brachial Index at 30 days, 12 and 24 months compared to Baseline is presented for the total number of patients where data were recorded, and the mean and standard deviation of the change. ABI is the ratio of blood pressure measured at the ankle to blood pressure measured at the arms. It is used to predict the severity of peripheral arterial disease. An ABI of >0.9-1.2 is considered normal, ≤ 0.9 indicates mild to moderate peripheral arterial disease, < 0.4 indicates severe peripheral arterial disease (ischemic pain and ulceration).	Baseline, Day 30, 12-month and 24-month.
Number of Participants With Reported Stent Fracture	Site reported number of participants with stent fracture through 24 months. Stent fracture is defined as clear interruption of stent strut observed in a minimum of two projections, determined by examination of X-ray images. Stent Strut Fracture Types: Type 0: No strut fractures. Type I: Single strut fracture only. Type II: Multiple single strut fractures that can occur at different sites. Type III: Multiple strut fractures resulting in complete transection of the stent, without displacement of the stent segments. Type IV: Multiple strut fractures resulting in displacement of segments of the stent. Type V: Spiral strut fracture.	30 day, 12 and 24 Months.

Collaborators and Investigators

• Sponsor: Veryan Medical Ltd.
• Investigators: Principal Investigator: Michael Lichtenberg, MD, Klinikum Arnsberg

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: August 25, 2016
• First Submitted That Met QC Criteria: September 9, 2016
• First Posted (Estimated): September 15, 2016

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: PAD; PVD; SFA stent
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: MIMICS-3D