Table 1: The MIMICS Clinical Trial Program.

TrialMIMICS (NCT02163863)MIMICS-2 (NCT02400905)MIMICS 3D (NCT02900924)

StructureRandomized controlled trialProspective registry, IDE studyProspective registry, postmarket surveillance

EnrollmentHelical centerline arm ()
Control stent arm ()
271 patientsUp to 500 real-world patients

Sites/location8 sites/Germany35 sites/United States
6 sites/German
6 sites/Japan
25 sites/Europe

Lesion typeStenotic or occlusive lesions in the SFA; restenotic lesions permittedStenotic or occlusive lesions in the femoropopliteal arteryStenotic or occlusive lesions in the femoropopliteal artery

Adjudication structureCore labs: angiography, duplex ultrasound, X-rayCore labs: angiography, duplex ultrasound, X-ray
Independent clinical events committee
Independent clinical events committee

Primary endpointsObjective performance goal efficacy and safety targetsObjective performance goal efficacy and safety targetsEfficacy: Freedom from CDTLR at 12 months
Safety: Composite of MAE at 30 days

Secondary endpointsPrimary patency
CDTLR
Changes in Rutherford classification
Changes in ABI measurements
Primary patency
CDTLR
Changes in Rutherford classification
Changes in ABI measurements
Changes in walking impairment questionnaire
Primary patency
Changes in Rutherford classification
Changes in ABI measurements

Subgroup analysesPost hoc geometric analyses
Presence and quantification of stented segment curvature based on geometric analysis of extended-leg and bent-knee X-ray measurements
Presence and quantification of shear stress based on computational fluid dynamic modeling of duplex ultrasound data and bent-knee X-ray measurements
Presence and quantification of shear stress based on computational fluid dynamic modeling of duplex ultrasound data and bent-knee X-ray measurementsAdjunctive stenting with DCBs ()
Popliteal lesions
Calcified lesions

Inclusion criteriaPatients with Rutherford category 1 to 4 with symptoms considered due to SFA disease
Lesion length: 4 cm to 10 cm, capable of being treated by a single stent
Patients with Rutherford category 2 to 4 due to PAD
Lesion length: 4 cm to 14 cm capable of being treated by a single stent or by multiple stents
Patients with documented PAD who receive the helical centerline stent in accordance with the IFU

Exclusion criteriaPrevious interventions at target site within 6 months
Previous stent placement in target limb
Target lesion(s) requires percutaneous interventional treatment, beyond standard balloon angioplasty alone, prior to placement of the study stentPatients whose lesions that cannot be crossed with a wire and/or balloon catheter and cannot be dilated sufficiently to allow passage of the delivery system

Follow-up24 months36 months36 months

StatusPublished results (Zeller et al. [25])12-month results expected in 201812-month results expected in 2018

ABI, ankle/brachial index; CDTLR, clinically driven target lesion revascularization; DCB, drug-coated balloon; IDE, investigational device exemption; IFU, instructions for use; MAE, major adverse events; PAD, peripheral artery disease; SFA, superficial femoral artery; TASC, Trans-Atlantic Inter-Society Consensus.