Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System (MIMICS-2)
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|ClinicalTrials.gov Identifier: NCT02400905|
Recruitment Status : Active, not recruiting
First Posted : March 27, 2015
Results First Posted : January 18, 2019
Last Update Posted : January 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Device: BioMimics 3D Stent System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||271 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||MIMICS-2: Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System in the Femoropopliteal Arteries of Patients With Symptomatic Peripheral Arterial Disease|
|Actual Study Start Date :||June 29, 2015|
|Actual Primary Completion Date :||November 8, 2017|
|Estimated Study Completion Date :||December 2019|
Experimental: BioMimics 3D Stent
Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
Device: BioMimics 3D Stent System
- Primary Safety Endpoint (Freedom From a Composite of Major Adverse Events (MAE) [ Time Frame: 30 days ]Freedom from a composite of major adverse events (MAE) comprising death, any major amputation performed on the target limb or clinically-driven target lesion revascularization (TLR) through 30 days.
- Primary Effectiveness Endpoint (Primary Stent Patency Rate) [ Time Frame: 12 months ]Primary stent patency rate at 12 months.
- Secondary Safety (Overall MAE Rate at 30 Days) [ Time Frame: 30 Days ]Contribution of individual MAE rates for death, major amputation performed on the target limb and clinically-driven target lesion revascularization to the overall MAE rate at 30 days.
- Long Term Safety (Overall MAE Rate at Month 12) [ Time Frame: 12 months ]Overall MAE rate at Month 12 and contribution of individual event rates to the overall MAE.
- Long Term Safety (Overall Rate and Incidence of Type of Serious Adverse Events) [ Time Frame: 36 Months ]Overall rate and incidence of type of serious adverse events from Day 0 through completion of Study follow-up at Month 36.
- Technical Success [ Time Frame: Procedural (at end of index procedure) ]Percentage of subjects in which a final result of ≤50% residual diameter stenosis (in-stent) was achieved at index procedure
- Primary Stent Patency [ Time Frame: Months 12 & 24 ]Determined at Months-12 and 24 using values of: PSVR >2.0, >2.4; >2.5; and >3.5, each to indicate loss of patency on duplex ultrasound or where angiography reveals >50% diameter stenosis or where the subject undergoes clinically-driven TLR.
- Clinical Outcome (Rutherford Clinical Category) [ Time Frame: Baseline, Day 30, Months 12 & 24 ]Comparison of Rutherford Clinical Category measured at Baseline, Day 30, Months 12 and 24.
- Clinical Outcome (Six-Minute Walk Test) [ Time Frame: Baseline, Day 30, Months 12 & 24 ]Comparison of measured at Baseline, Day 30, Months 12 and 24 (subgroup of US investigational sites only).
- Functional Outcome (Ankle Brachial Index (ABI) Measurement) [ Time Frame: Day 30, Months 12 & 24 ]Comparison of the ankle brachial index (ABI) measurement at Baseline, within 30 days after index procedure, then at Months 12 and 24.
- Functional Outcome (Walking Impairment Questionnaire) [ Time Frame: Baseline, Day 30, Months 12 & 24 ]Comparison of the Walking Impairment Questionnaire at Baseline, within 30 days after index procedure, then at Months 12 and 24.
- Stent Integrity (Measured as Freedom From Stent Fracture) [ Time Frame: Months 12, 24 & 36 ]Stent integrity measured as freedom from stent fracture.
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): NCT02400905
|Principal Investigator:||Timothy M. Sullivan, MD||Minneapolis Heart Institute / Abbott Northwestern Hospital|
|Principal Investigator:||Thomas Zeller, MD||Herz-Zentrum University Hospital|
|Principal Investigator:||Masato Nakamura, MD||Toho University Ohashi Medical Center|