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: Unknown
• 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
    • Universitätsklinikum Tübingen
  • Villingen-Schwenningen, Germany, D-78052
    • Schwarzwald-Baar-Klinikum
• Netherlands
  • Arnhem, Netherlands
    • Rijnstate hospital
  • Groningen, Netherlands
    • University Medical Center Groningen
• 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
• Genders Eligible for Study: All

• 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
Freedom from a composite of major adverse events (MAE) (Primary Safety Endpoint)	Number of participants free from 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
Freedom 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
Acute technical success defined as achievement of a final residual diameter stenosis ≤30% at the end of the procedure	Number of participants with final residual diameter stenosis ≤30% at the end of the index procedure	Procedural
Acute procedural success defined as acute technical success and absence of peri-procedural adverse events.	Number of participants with acute technical success 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 h of the index procedure.	72 hours
Incidence of individual components of MAE	Incidence of individual components of MAE (death, any major amputation performed on the index limb or CDTLR) through 36 months	30 days, 12, 24 and 36 months
Overall rate and incidence of adverse events from Day 0 through completion of study follow-up at Month 36.	Overall rate and incidence of all adverse events reported from Day 0 through completion of study follow-up at Month 36.	36 months
Stent patency	Stent patency rate assessed by duplex ultrasound, as available, determined at Months 12, 24 and 36. This will be assessed using values of peak systolic velocity ratio (PSVR) >2.0, >2.4; >2.5; and >3.5 each to indicate loss of patency on duplex ultrasound.	12, 24 and 36 months
Rutherford Clinical Category	Comparison of Rutherford Clinical Category measured at Baseline, Day 30, Months 12 24 and 36.	Baseline, Day 30, Months 12 24 and 36
Functional outcome (ankle brachial index (ABI) measurement)	Comparison of the ankle brachial index (ABI) measurement at Baseline, within 30 days after index procedure, then at Months 12, 24 and 36.	Baseline, Day 30, Months 12, 24 and 36.

Collaborators and Investigators

• Sponsor: Veryan Medical Ltd.

Study record dates

Study Major Dates

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

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): November 13, 2019
• Last Update Submitted That Met QC Criteria: November 12, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

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