Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D (MIMICS-3D)
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|ClinicalTrials.gov Identifier: NCT02900924|
Recruitment Status : Active, not recruiting
First Posted : September 15, 2016
Last Update Posted : November 13, 2019
|Condition or disease||Intervention/treatment|
|Peripheral Arterial Disease||Device: BioMimics 3D Stent|
The MIMICS-3D study is a prospective, multicentre, observational study of the BioMimics 3D Stent System in patients undergoing endovascular intervention to relieve symptomatic peripheral arterial disease of the femoropopliteal artery. The study is designed to enable the collection, analysis and reporting of data from "real-world" use of the BioMimics 3D Stent System used in accordance with the Instructions for Use (IFU) associated with the product's CE Mark approval.
Data collection will include that relating to safety, effectiveness and device performance and the period of observation during which data will be collected will extend from the index procedure through 3 years (36 months), according to the standard follow-up practice of the enrolling institution.
|Study Type :||Observational|
|Actual Enrollment :||507 participants|
|Official Title:||A Prospective, Multicentre Observational Study to Evaluate the BioMimics 3D Self-Expanding Stent System in the Treatment of Peripheral Arterial Disease: MIMICS-3D|
|Actual Study Start Date :||September 2016|
|Actual Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2021|
- Freedom from a composite of major adverse events (MAE) (Primary Safety Endpoint) [ Time Frame: 30 days ]Number of participants free from composite of major adverse events (MAE) comprising death, any major amputation performed on the index limb or clinically-driven target lesion revascularization (CDTLR) through 30 days.
- Freedom from clinically-driven target lesion revascularization (CDTLR) (Primary Effectiveness Endpoint) [ Time Frame: 12 months ]Number of participants free from clinically-driven target lesion revascularization (CDTLR) through 12 months.
- Acute technical success defined as achievement of a final residual diameter stenosis ≤30% at the end of the procedure [ Time Frame: Procedural ]Number of participants with final residual diameter stenosis ≤30% at the end of the index procedure
- Acute procedural success defined as acute technical success and absence of peri-procedural adverse events. [ Time Frame: 72 hours ]Number of participants with acute technical success and absence of the following adverse events: death, stroke, myocardial infarction, acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and/or need for urgent/emergent vascular surgery, within 72 h of the index procedure.
- Incidence of individual components of MAE [ Time Frame: 30 days, 12, 24 and 36 months ]Incidence of individual components of MAE (death, any major amputation performed on the index limb or CDTLR) through 36 months
- Overall rate and incidence of adverse events from Day 0 through completion of study follow-up at Month 36. [ Time Frame: 36 months ]Overall rate and incidence of all adverse events reported from Day 0 through completion of study follow-up at Month 36.
- Stent patency [ Time Frame: 12, 24 and 36 months ]Stent patency rate assessed by duplex ultrasound, as available, determined at Months 12, 24 and 36. This will be assessed using values of peak systolic velocity ratio (PSVR) >2.0, >2.4; >2.5; and >3.5 each to indicate loss of patency on duplex ultrasound.
- Rutherford Clinical Category [ Time Frame: Baseline, Day 30, Months 12 24 and 36 ]Comparison of Rutherford Clinical Category measured at Baseline, Day 30, Months 12 24 and 36.
- Functional outcome (ankle brachial index (ABI) measurement) [ Time Frame: Baseline, Day 30, Months 12, 24 and 36. ]Comparison of the ankle brachial index (ABI) measurement at Baseline, within 30 days after index procedure, then at Months 12, 24 and 36.
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): NCT02900924
|Principal Investigator:||Michael Lichtenberg, MD||Klinikum Arnsberg|