MIMICS-3D-USA Registry Study

Sponsor

Veryan Medical Ltd. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04640597

Collaborator

(none)

500

Enrollment

Locations

56.5

Anticipated Duration (Months)

16.1

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease	Device: BioMimics 3D Vascular Stent System

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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Dec 18, 2020

Anticipated Primary Completion Date :

Sep 4, 2023

Anticipated Study Completion Date :

Sep 4, 2025

Outcome Measures

Primary Outcome Measures

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. [30 Days]
Freedom from major adverse events expressed as a percentage
Primary effectiveness endpoint of number of subjects of freedom from CEC Adjudicated clinically driven target lesion revascularization (CDTLR) through 12 months [12 months]
Freedom from CDTLR at 12 Months expressed as a percentage

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alabama Clinical Therapeutics, LLC	Birmingham	Alabama	United States	35235
2	Cardiovascular Associates of the Southeast	Birmingham	Alabama	United States	35243
3	Pulse Cardiovascular Institute	Scottsdale	Arizona	United States	85251
4	St Helena Hospital dba Adventist Health	Saint Helena	California	United States	94574
5	Vascular Care Connecticut	Darien	Connecticut	United States	06820
6	Cardiovascular Solutions Institute	Bradenton	Florida	United States	34208
7	Palm Vascular Centers	Miami Beach	Florida	United States	33140
8	Coastal Vascular & Interventional, PLLC	Pensacola	Florida	United States	32504
9	Midwest Cardiovascular Research Foundation	Davenport	Iowa	United States	52801
10	Coastal Vascular & Interventional, PLLC	Davenport	Iowa	United States	52807
11	University of Iowa	Iowa City	Iowa	United States	52242
12	CIS Clinical Research Corporation	Houma	Louisiana	United States	70360
13	Louisiana Cardiovascular & Limb Salvage Center	Lafayette	Louisiana	United States	70503
14	Vascular Care Group	Wellesley	Massachusetts	United States	02482
15	William Beaumont Hospital	Royal Oak	Michigan	United States	48073
16	University of Missouri	Columbia	Missouri	United States	65212
17	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
18	NJ Endovascular and Amputation Prevention, LLP	Clifton	New Jersey	United States	07013
19	Cardiac And Vascular Interventions of NJ	New Brunswick	New Jersey	United States	08901
20	Columbia University Irving Medical Center/NYPH	New York	New York	United States	10032
21	Columbia University Medical Center	New York	New York	United States	10032
22	Amputation Prevention Center of North Carolina	Cary	North Carolina	United States	27518
23	Advanced Cardiovascular Solutions	Oklahoma City	Oklahoma	United States	73134
24	University of Oklahoma, Department of Surgery	Tulsa	Oklahoma	United States	74104
25	US cardiovascular of Greenburg	Jefferson Hills	Pennsylvania	United States	15025
26	Ascension Seton Heart Institute	Austin	Texas	United States	78705
27	Cardiothoracic and Vascular Surgeons	Austin	Texas	United States	78756
28	Baylor St Lukes Medical Center	Houston	Texas	United States	77030
29	North Dallas Research Associates	McKinney	Texas	United States	75609
30	Hurricane Cardiology Research	New Braunfels	Texas	United States	78130
31	AZH Wound & Vascular Center	Milwaukee	Wisconsin	United States	53221