Peripheral Arterial Disease
Conditions
Keywords
PAD, PVD, SFA stent, stent, Helical stent, Vascular stent
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.
Interventions
Patients with BioMimics 3D Vascular Stent System
Sponsors
Veryan Medical Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed