MIMICS-3D-USA Registry Study

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04640597
• Other study ID #: MIMICS-3D-USA
• Status: Active, not recruiting
• Start date: December 18, 2020
• Est. completion date: September 4, 2025

Study information

• Verified date: November 2022
• Source: Veryan Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: September 4, 2025
• Est. primary completion date: September 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• BioMimics 3D Vascular Stent System
Patients with BioMimics 3D Vascular Stent System

Locations

Country	Name	City	State
United States	Ascension Seton Heart Institute	Austin	Texas
United States	Cardiothoracic and Vascular Surgeons	Austin	Texas
United States	Alabama Clinical Therapeutics, LLC	Birmingham	Alabama
United States	Cardiovascular Associates of the Southeast	Birmingham	Alabama
United States	Cardiovascular Solutions Institute	Bradenton	Florida
United States	Amputation Prevention Center of North Carolina	Cary	North Carolina
United States	NJ Endovascular and Amputation Prevention, LLP	Clifton	New Jersey
United States	University of Missouri	Columbia	Missouri
United States	Vascular Care Connecticut	Darien	Connecticut
United States	Coastal Vascular & Interventional, PLLC	Davenport	Iowa
United States	Midwest Cardiovascular Research Foundation	Davenport	Iowa
United States	CIS Clinical Research Corporation	Houma	Louisiana
United States	Baylor St Lukes Medical Center	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	US cardiovascular of Greenburg	Jefferson Hills	Pennsylvania
United States	North Dallas Research Associates	McKinney	Texas
United States	Palm Vascular Centers	Miami Beach	Florida
United States	AZH Wound & Vascular Center	Milwaukee	Wisconsin
United States	Hurricane Cardiology Research	New Braunfels	Texas
United States	Cardiac And Vascular Interventions of NJ	New Brunswick	New Jersey
United States	Columbia University Irving Medical Center/NYPH	New York	New York
United States	Columbia University Medical Center	New York	New York
United States	Advanced Cardiovascular Solutions	Oklahoma City	Oklahoma
United States	Coastal Vascular & Interventional, PLLC	Pensacola	Florida
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Pulse Cardiovascular Institute	Scottsdale	Arizona
United States	Vascular Care Group	Wellesley	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Veryan Medical Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Freedom from major adverse events expressed as a percentage	30 Days
Primary	Primary effectiveness endpoint of number of subjects of freedom from CEC Adjudicated clinically driven target lesion revascularization (CDTLR) through 12 months	Freedom from CDTLR at 12 Months expressed as a percentage	12 months
Secondary	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.	Number of participants with final residual stenosis =30%	Procedural
Secondary	Procedural success defined as technical success with absence of MAE (comprising death,	Number of participants with acute technical success and absence of MAE	24 hours after index procedure
Secondary	Incidence of components of CEC-adjudicated MAE.	Incidence of individual components of CEC-adjudicated MAE (death, any unplanned major amputation performed on the index limb or CDTLR).	30 days, 12, 24 and 36 months
Secondary	Overall rate and incidence of adverse events	Overall rate and incidence of adverse events from Day 0 to completion of study follow-up at month 36	36 Months
Secondary	Primary Stent Patency rate determined by core lab adjudicated, duplex ultrasound at 12 Months	Primary Stent Patency expressed as a percentage	12 Months
Secondary	Comparison of mean Rutherford Clinical Category measured at Baseline, Day 30, Months 12, 24 and 36.	Compare RCC at each of the follow-up visit with the Baseline	Baseline, Day 30, Months 12, 24 and 36.
Secondary	Functional outcome: ankle brachial index measurement comparison	Comparison of the ankle brachial index (ABI) measurement at Baseline, within 30 days after index procedure, then at Month 12.	Baseline, within 30 days after index procedure, then at Month 12.
Secondary	Comparison of the quality of life (QoL) score at Baseline, within 30 days after index procedure, then at Months 12, 24 and 36	Compare the change in QoL score compared to the Baseline	Baseline, Day 30, Months 12, 24 and 36.
Secondary	Incidence of stent fractures	Incidence of reported stent fracture reported by investigational sites through 36 months	36 Months