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

NCT02900924 | Completed Results DMC

• 1 other identifier: MIMICS-3D
• Study Type: observational
• Target: 507
• Locations: 4 countries
• Sites: 23

Brief Summary

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

Conditions

Peripheral Arterial Disease

Keywords

PAD; PVD; SFA stent

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Number of Participants With a Final Residual Diameter Stenosis ≤30% at the End 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

  Within 72 hours of index procedure.

• Percent Probability of Individual Components of MAE

  30 days, 12 Months, and 24 Months.

• Number of Participants With Adverse Events

  30 day, 12 and 24 months

• Stent Patency Rate

  12 and 24 months.

Interventions

BioMimics 3D Stent DEVICE

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Veryan Medical Ltd.: lead

Study Sites (23)

OLV Hospital

Aalst, Belgium

Location

ZNA Vascular Clinic/ZNA Stuivenburg Hospital

Antwerp, Belgium

Location

AZ Sint Blasius

Dendermonde, Belgium

Location

AZ Maria Middelares

Ghent, Belgium

Location

Regionaal Vaartcentrum , AZ Helig Hart Tienen

Tienen, Belgium

Location

Karolinen-Hospital

Arnsberg, Germany

Location

Universitaets-Herzzentrum Freiburg-Bad Krozingen

Bad Krozingen, Germany

Location

KEH Berlin

Berlin, Germany

Location

Vivantes Klinikum Friedrichshain

Berlin, Germany

Location

Krankenhaus Buchholz

Buchholz, Germany

Location

Krankenhaus Dresden-Friedrichstadt, Städtisches Klinikum

Dresden, 01067, Germany

Location

Universitätsklinikum Essen

Essen, Germany

Location

CCB im Agaplesion Bethanien Krankenhaus

Frankfurt am Main, 60389, Germany

Location

Asklepios Klinik Harburg

Hamburg, 21075, Germany

Location

UKE (University Hospital Hamburg)

Hamburg, Germany

Location

Universitätsklinikum Leipzig AöR

Leipzig, Germany

Location

Gefäßpraxis im Tal

Munich, Germany

Location

Marienhospital Osnabrück GmbH

Osnabrück, Germany

Location

RoMed Klinikum Rosenheim

Rosenheim, 83022, Germany

Location

SRH-Klinikum Zentralklinikum Suhl

Suhl, 98527, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72016, Germany

Location

Rijnstate Hospital

Arnhem, Netherlands

Location

Skane University Hospital

Malmo, Sweden

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Nick Yeo
• Organization: Veryan Medical

nick.yeo@veryanmed.com

+441403258984

Study Officials

• Michael Lichtenberg, MD

  Klinikum Arnsberg

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: September 15, 2016
• Study Start: September 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: September 1, 2021
• Last Updated: April 17, 2025
• Results First Posted: April 17, 2025

Record last verified: 2025-03

Locations

NL (1); BE (5); DE (16); SE (1)