MIMICS-3D-USA Registry Study
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|ClinicalTrials.gov Identifier: NCT04640597|
Recruitment Status : Active, not recruiting
First Posted : November 23, 2020
Last Update Posted : November 16, 2022
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|Condition or disease||Intervention/treatment|
|Peripheral Arterial Disease||Device: BioMimics 3D Vascular Stent System|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||500 participants|
|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 :||September 4, 2023|
|Estimated Study Completion Date :||September 4, 2025|
- Device: BioMimics 3D Vascular Stent System
Patients with BioMimics 3D Vascular Stent System
- 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
- 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
- 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%
- 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
- 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).
- 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
- 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
- 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
- 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.
- 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
- Incidence of stent fractures [ Time Frame: 36 Months ]Incidence of reported stent fracture reported by investigational sites through 36 months
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|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|
- 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.
- 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
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
|Study Director:||Nuwani Edirisinghe||Veryan Medical|
|Responsible Party:||Veryan Medical Ltd.|
|Other Study ID Numbers:||
|First Posted:||November 23, 2020 Key Record Dates|
|Last Update Posted:||November 16, 2022|
|Last Verified:||November 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|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|
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases