Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04640597
Other study ID # MIMICS-3D-USA
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT06032065 - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD) Phase 3
Active, not recruiting NCT03987061 - MOTIV Bioresorbable Scaffold in BTK Artery Disease N/A
Recruiting NCT03506633 - Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients N/A
Active, not recruiting NCT03506646 - Dietary Nitrate Supplementation and Thermoregulation N/A
Active, not recruiting NCT04677725 - NEtwork to Control ATherothrombosis (NEAT Registry)
Recruiting NCT05961943 - RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients N/A
Recruiting NCT06047002 - Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease
Completed NCT03185052 - Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach N/A
Recruiting NCT05992896 - A Study of Loco-Regional Liposomal Bupivacaine Injection Phase 4
Completed NCT04635501 - AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial N/A
Recruiting NCT04584632 - The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery N/A
Withdrawn NCT03994185 - The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease N/A
Withdrawn NCT03538392 - Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
Recruiting NCT02915796 - Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty Phase 1
Active, not recruiting NCT02900924 - Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D
Completed NCT02901847 - To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities. N/A
Not yet recruiting NCT02455726 - Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease N/A
Not yet recruiting NCT02387450 - Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication Phase 2/Phase 3
Withdrawn NCT02126540 - Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries N/A
Completed NCT02384980 - Saving Life and Limb: FES for the Elderly With PAD Phase 1