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MIMICS-3D-USA Registry Study

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ClinicalTrials.gov Identifier: NCT04640597
Recruitment Status : Recruiting
First Posted : November 23, 2020
Last Update Posted : September 22, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
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 : December 18, 2020
Estimated Primary Completion Date : December 18, 2023
Estimated Study Completion Date : December 18, 2025

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. 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. [ Time Frame: 30 Days ]
    Freedom from major adverse events expressed as a percentage

  2. Primary effectiveness endpoint of number of subjects of freedom from CEC Adjudicated clinically driven target lesion revascularization (CDTLR) through 12 months [ Time Frame: 12 months ]
    Freedom from CDTLR at 12 Months expressed as a percentage


Secondary Outcome Measures :
  1. 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. [ Time Frame: Procedural ]
    Number of participants with final residual stenosis ≤30%

  2. Procedural success defined as technical success with absence of MAE (comprising death, [ Time Frame: 24 hours after index procedure ]
    Number of participants with acute technical success and absence of MAE

  3. Incidence of components of CEC-adjudicated MAE. [ Time Frame: 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).

  4. Overall rate and incidence of adverse events [ Time Frame: 36 Months ]
    Overall rate and incidence of adverse events from Day 0 to completion of study follow-up at month 36

  5. Primary Stent Patency rate determined by core lab adjudicated, duplex ultrasound at 12 Months [ Time Frame: 12 Months ]
    Primary Stent Patency expressed as a percentage

  6. Comparison of mean Rutherford Clinical Category measured at Baseline, Day 30, Months 12, 24 and 36. [ Time Frame: Baseline, Day 30, Months 12, 24 and 36. ]
    Compare RCC at each of the follow-up visit with the Baseline

  7. Functional outcome: ankle brachial index measurement comparison [ Time Frame: 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.

  8. Comparison of the quality of life (QoL) score at Baseline, within 30 days after index procedure, then at Months 12, 24 and 36 [ Time Frame: Baseline, Day 30, Months 12, 24 and 36. ]
    Compare the change in QoL score compared to the Baseline

  9. Incidence of stent fractures [ Time Frame: 36 Months ]
    Incidence of reported stent fracture reported by investigational sites through 36 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04640597


Contacts
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Contact: LeRoy Moriuchi +1 240 641 1718 Leroy.moriuchi@veryanmed.com

Locations
Show Show 23 study locations
Sponsors and Collaborators
Veryan Medical Ltd.
Investigators
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Study Director: Nuwani Edirisinghe Veryan Medical
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Responsible Party: Veryan Medical Ltd.
ClinicalTrials.gov Identifier: NCT04640597    
Other Study ID Numbers: MIMICS-3D-USA
First Posted: November 23, 2020    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Veryan Medical Ltd.:
PAD
PVD
SFA stent
stent
Helical stent
Vascular stent
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases