Clinical trial NCT04640597: MIMICS-3D-USA Registry Study
Official title: A Prospective, Multicentre Observational Study to Evaluate the BioMimics 3D Vascular Stent System in the Treatment of Peripheral Arterial Disease: MIMICS-3D-USA
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Peripheral Arterial Disease
Keywords: PAD
PVD
SFA stent
stent
Helical stent
Vascular stent
Lead sponsor: Veryan Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2020-11-23
Enrollment: 500
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 Vascular Stent System in accordance with the current approved FDA (PMA # 180003 approval) indication for use as stated in the Instructions for Use (IFU) will be consecutively enrolled in this study

Brief summary: The MIMICS-3D-USA Study is a prospective, multicentre, observational study (non-investigational) of the BioMimics 3D Vascular Stent System that evaluates evaluate safety, effectiveness and device performance within a real-world clinical population of patients undergoing femoropopliteal intervention for the treatment of peripheral artery disease.

Detailed description: The MIMICS-3D-USA Study is designed to enable the collection, analysis, reporting and presentation of data from use of the BioMimics 3D Vascular Stent System purchased by the hospital / institution or office interventional suite and used in accordance with the IFU associated with the product's FDA approval. The intent of this post-market observational study is to increase the understanding of the performance of the BioMimics 3D Vascular Stent System in a larger population of patients representative of a real-world situation within US hospitals, institutions and office-based interventional suites or labs.

Eligibility criteria: Inclusion Criteria:

* Patient is age ≥18 and ≤85 years at the 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 Vascular Stent System in accordance with the 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 or severe hypertension.
* 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

Primary outcomes:
measure: Safety endpoint of number of subjects of freedom from CEC-adjudicated major adverse events (MAE) comprising death, any unplanned major amputation performed on the index limb or clinically driven target lesion revascularization (CDTLR) through 30 days.
timeFrame: 30 Days
measure: Primary effectiveness endpoint of number of subjects of freedom from CEC Adjudicated clinically driven target lesion revascularization (CDTLR) through 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Technical success defined as delivery and deployment of the study stent to achieve a final residual diameter stenosis of ≤30% measured by visual assessment of angiographic imaging at the end of the study procedure on Day 0.
timeFrame: Procedural
measure: Procedural success defined as technical success with absence of MAE (comprising death,
timeFrame: 24 hours after index procedure
measure: Incidence of components of CEC-adjudicated MAE.
timeFrame: 30 days, 12, 24 and 36 months
measure: Overall rate and incidence of adverse events
timeFrame: 36 Months
measure: Primary Stent Patency rate determined by core lab adjudicated, duplex ultrasound at 12 Months
timeFrame: 12 Months
measure: Comparison of mean Rutherford Clinical Category measured at Baseline, Day 30, Months 12, 24 and 36.
timeFrame: Baseline, Day 30, Months 12, 24 and 36.
measure: Functional outcome: ankle brachial index measurement comparison
timeFrame: Baseline, within 30 days after index procedure, then at Month 12.
measure: Comparison of the quality of life (QoL) score at Baseline, within 30 days after index procedure, then at Months 12, 24 and 36
timeFrame: Baseline, Day 30, Months 12, 24 and 36.
measure: Incidence of stent fractures
timeFrame: 36 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Birmingham
country: United States
facility: Cardiovascular Associates of the Southeast
state: Alabama
city: Scottsdale
country: United States
facility: Pulse Cardiovascular Institute
state: Arizona
city: Darien
country: United States
facility: Vascular Care Connecticut
state: Connecticut
city: Bradenton
country: United States
facility: Cardiovascular Solutions Institute
state: Florida
city: Miami Beach
country: United States
facility: Palm Vascular Centers
state: Florida
city: Pensacola
country: United States
facility: Coastal Vascular & Interventional, PLLC
state: Florida
city: Davenport
country: United States
facility: Midwest Cardiovascular Research Foundation
state: Iowa
city: Davenport
country: United States
facility: Coastal Vascular & Interventional, PLLC
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Houma
country: United States
facility: CIS Clinical Research Corporation
state: Louisiana
city: Wellesley
country: United States
facility: Vascular Care Group
state: Massachusetts
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Clifton
country: United States
facility: NJ Endovascular and Amputation Prevention, LLP
state: New Jersey
city: New Brunswick
country: United States
facility: Cardiac And Vascular Interventions of NJ
state: New Jersey
city: New York
country: United States
facility: Columbia University Irving Medical Center/NYPH
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Cary
country: United States
facility: Amputation Prevention Center of North Carolina
state: North Carolina
city: Oklahoma City
country: United States
facility: Advanced Cardiovascular Solutions
state: Oklahoma
city: Jefferson Hills
country: United States
facility: US cardiovascular of Greenburg
state: Pennsylvania
city: Austin
country: United States
facility: Ascension Seton Heart Institute
state: Texas
city: Austin
country: United States
facility: Cardiothoracic and Vascular Surgeons
state: Texas
city: Houston
country: United States
facility: Baylor St Lukes Medical Center
state: Texas
city: McKinney
country: United States
facility: North Dallas Research Associates
state: Texas
city: New Braunfels
country: United States
facility: Hurricane Cardiology Research
state: Texas
city: Milwaukee
country: United States
facility: AZH Wound & Vascular Center
state: Wisconsin
Study officials:
affiliation: Veryan Medical
name: Nuwani Edirisinghe
role: STUDY_DIRECTOR
References: