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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02900924
Other study ID # MIMICS-3D
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 2016
Est. completion date October 2021

Study information

Verified date November 2019
Source Veryan Medical Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 507
Est. completion date October 2021
Est. primary completion date October 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Intervention

Device:
BioMimics 3D Stent


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Veryan Medical Ltd.

Countries where clinical trial is conducted

Belgium,  Germany,  Netherlands,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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.
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