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Stent

Treatment for Peripheral Arterial Disease

N/A
Waitlist Available
Research Sponsored by Veryan Medical Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

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.

Eligible Conditions
  • Peripheral Arterial Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary effectiveness endpoint of number of subjects of freedom from CEC Adjudicated clinically driven target lesion revascularization (CDTLR) through 12 months
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.
Secondary outcome measures
Comparison of mean Rutherford Clinical Category measured at Baseline, Day 30, Months 12, 24 and 36.
Comparison of the quality of life (QoL) score at Baseline, within 30 days after index procedure, then at Months 12, 24 and 36
Functional outcome: ankle brachial index measurement comparison
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Who is running the clinical trial?

Veryan Medical Ltd.Lead Sponsor
4 Previous Clinical Trials
918 Total Patients Enrolled
3 Trials studying Peripheral Arterial Disease
864 Patients Enrolled for Peripheral Arterial Disease
Nuwani EdirisingheStudy DirectorVeryan Medical
~107 spots leftby Sep 2025
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