Clinical trial NCT02900924: Observational Study to Evaluate the BioMimics 3D Stent System: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Keywords: PAD
PVD
SFA stent
Lead sponsor: Veryan Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2016-09-15
Enrollment: 507
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Free From Major Adverse Events (MAE)
timeFrame: 30 days
measure: Number of Participants Free From Clinically-driven Target Lesion Revascularization (CDTLR)
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants With a Final Residual Diameter Stenosis ≤30% at the End of the Index Procedure
timeFrame: Within 72 hours of the index procedure.
measure: Number of Participants With Acute Technical Success and Absence of the Adverse Events Listed in the Description
timeFrame: Within 72 hours of index procedure.
measure: Percent Probability of Individual Components of MAE
timeFrame: 30 days, 12 Months, and 24 Months.
measure: Number of Participants With Adverse Events
timeFrame: 30 day, 12 and 24 months
measure: Stent Patency Rate
timeFrame: 12 and 24 months.
measure: Comparison of Rutherford Clinical Category
timeFrame: Baseline, Day 30, 12 months and 24 months
measure: Comparison of Ankle Brachial Index (ABI) Measurement
timeFrame: Baseline, Day 30, 12-month and 24-month.
measure: Number of Participants With Reported Stent Fracture
timeFrame: 30 day, 12 and 24 Months.
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Hospital
city: Antwerp
country: Belgium
facility: ZNA Vascular Clinic/ZNA Stuivenburg Hospital
city: Dendermonde
country: Belgium
facility: AZ Sint Blasius
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Tienen
country: Belgium
facility: Regionaal Vaartcentrum , AZ Helig Hart Tienen
city: Arnsberg
country: Germany
facility: Karolinen-Hospital
city: Bad Krozingen
country: Germany
facility: Universitaets-Herzzentrum Freiburg-Bad Krozingen
city: Berlin
country: Germany
facility: KEH Berlin
city: Berlin
country: Germany
facility: Vivantes Klinikum Friedrichshain
city: Buchholz
country: Germany
facility: Krankenhaus Buchholz
city: Dresden
country: Germany
facility: Krankenhaus Dresden-Friedrichstadt, Städtisches Klinikum
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Frankfurt am Main
country: Germany
facility: CCB im Agaplesion Bethanien Krankenhaus
city: Hamburg
country: Germany
facility: Asklepios Klinik Harburg
city: Hamburg
country: Germany
facility: UKE (University Hospital Hamburg)
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig AöR
city: Munich
country: Germany
facility: Gefäßpraxis im Tal
city: Osnabruck
country: Germany
facility: Marienhospital Osnabrück GmbH
city: Rosenheim
country: Germany
facility: RoMed Klinikum Rosenheim
city: Suhl
country: Germany
facility: SRH-Klinikum Zentralklinikum Suhl
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Malmö
country: Sweden
facility: Skane University Hospital
Study officials:
affiliation: Klinikum Arnsberg
name: Michael Lichtenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: