MIMICS-3D-USA Registry Study

Active, not recruiting

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT04640597
• Lead Sponsor: Veryan Medical Ltd.

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.

Study Timeline

• Study First Submitted: 2020-11-13
• Study First Submitted QC: 2020-11-20
• Study First Posted: 2020-11-23
• Study Start: 2020-12-18
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-15
• Last Update Posted: 2022-11-16
• Primary Completion: 2023-09-04
• Study Completion: 2025-09-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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
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
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).
Incidence of stent fractures	36 Months	Incidence of reported stent fracture reported by investigational sites through 36 months
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%
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.
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 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
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

Trial Locations

Locations (26)

Alabama Clinical Therapeutics, LLC; 🇺🇸 Birmingham, Alabama, United States

Cardiovascular Associates of the Southeast; 🇺🇸 Birmingham, Alabama, United States

Pulse Cardiovascular Institute; 🇺🇸 Scottsdale, Arizona, United States

Vascular Care Connecticut; 🇺🇸 Darien, Connecticut, United States

Cardiovascular Solutions Institute; 🇺🇸 Bradenton, Florida, United States

Palm Vascular Centers; 🇺🇸 Miami Beach, Florida, United States

Coastal Vascular & Interventional, PLLC; 🇺🇸 Davenport, Iowa, United States

Midwest Cardiovascular Research Foundation; 🇺🇸 Davenport, Iowa, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

CIS Clinical Research Corporation; 🇺🇸 Houma, Louisiana, United States

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