N/A
Completed N=507
Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D
Source: ClinicalTrials.gov NCT02900924 ↗Enrolled (actual)
507
Serious AEs
55.6%
Results posted
Apr 2025
Primary outcomePrimary: Number of Participants Free From Major Adverse Events (MAE) — 489; 492; 492; 491 Participants
Summary
The MIMICS-3D study will evaluate safety, effectiveness and device performance within a real-world clinical population of patients undergoing femoropopliteal intervention.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Free From Major Adverse Events (MAE) |
489; 492; 492; 491 | — |
| PRIMARY Number of Participants Free From Clinically-driven Target Lesion Revascularization (CDTLR) |
396 | — |
| SECONDARY Number of Participants With a Final Residual Diameter Stenosis ≤30% at the End of the Index Procedure |
501 | — |
| SECONDARY Number of Participants With Acute Technical Success and Absence of the Adverse Events Listed in the Description |
494 | — |
| SECONDARY Percent Probability of Individual Components of MAE |
0.4; 0.4; 0.4; 6.1; 1.5; 9.4 | — |
| SECONDARY Number of Participants With Adverse Events |
84; 7; 36; 60; 6; 21 | — |
| SECONDARY Stent Patency Rate |
370; 381; 381; 388; 318; 324 | — |
| SECONDARY Comparison of Rutherford Clinical Category |
2; 6; 86; 289; 38; 72 | — |
| SECONDARY Comparison of Ankle Brachial Index (ABI) Measurement |
0.6; 1.0; 0.9; 0.9; 0.4; 0.3 | — |
| SECONDARY Number of Participants With Reported Stent Fracture |
0; 0; 3; 0; 0; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Patient is age ≥18 and ≤85 years at 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 stent in accordance with the approved CE Mark indication and Instructions for Use (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, severe hypertension or renal failure.
- 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 and follow-up visit schedules for patients undergoing femoropopliteal intervention.
Data sourced from ClinicalTrials.gov (NCT02900924). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.