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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.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioMimics 3D Vascular Stent System | Device | Patients with BioMimics 3D Vascular Stent System |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Procedural success defined as technical success with absence of MAE (comprising death, |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Nuwani Edirisinghe | Veryan Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | 35235 | United States | ||
| Cardiovascular Associates of the Southeast |
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Number of participants with acute technical success and absence of MAE |
| 24 hours after index procedure |
| 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 |
| 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 |
| Primary Stent Patency rate determined by core lab adjudicated, duplex ultrasound at 12 Months | Primary Stent Patency expressed as a percentage | 12 Months |
| 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. |
| 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. |
| 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. |
| Incidence of stent fractures | Incidence of reported stent fracture reported by investigational sites through 36 months | 36 Months |
| Birmingham |
| Alabama |
| 35243 |
| United States |
| Pulse Cardiovascular Institute | Scottsdale | Arizona | 85251 | United States |
| Vascular Care Connecticut | Darien | Connecticut | 06820 | United States |
| Cardiovascular Solutions Institute | Bradenton | Florida | 34208 | United States |
| Palm Vascular Centers | Miami Beach | Florida | 33140 | United States |
| Coastal Vascular & Interventional, PLLC | Pensacola | Florida | 32504 | United States |
| Midwest Cardiovascular Research Foundation | Davenport | Iowa | 52801 | United States |
| Coastal Vascular & Interventional, PLLC | Davenport | Iowa | 52807 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| CIS Clinical Research Corporation | Houma | Louisiana | 70360 | United States |
| Vascular Care Group | Wellesley | Massachusetts | 02482 | United States |
| University of Missouri | Columbia | Missouri | 65212 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| NJ Endovascular and Amputation Prevention, LLP | Clifton | New Jersey | 07013 | United States |
| Cardiac And Vascular Interventions of NJ | New Brunswick | New Jersey | 08901 | United States |
| Columbia University Irving Medical Center/NYPH | New York | New York | 10032 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Amputation Prevention Center of North Carolina | Cary | North Carolina | 27518 | United States |
| Advanced Cardiovascular Solutions | Oklahoma City | Oklahoma | 73134 | United States |
| US cardiovascular of Greenburg | Jefferson Hills | Pennsylvania | 15025 | United States |
| Ascension Seton Heart Institute | Austin | Texas | 78705 | United States |
| Cardiothoracic and Vascular Surgeons | Austin | Texas | 78756 | United States |
| Baylor St Lukes Medical Center | Houston | Texas | 77030 | United States |
| North Dallas Research Associates | McKinney | Texas | 75609 | United States |
| Hurricane Cardiology Research | New Braunfels | Texas | 78130 | United States |
| AZH Wound & Vascular Center | Milwaukee | Wisconsin | 53221 | United States |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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