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

Peripheral Arterial Disease Clinical Trial

— MIMICS-3D  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02900924
• Other study ID #: MIMICS-3D
• Status: Active, not recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

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.