| Eligibility |
Inclusion Criteria:
General Inclusion Criteria:
1. Subject must provide written informed consent prior to any clinical investigation
related procedure.
2. Subject has symptomatic Critical Limb Ischemia (CLI), Rutherford Becker Clinical
Category 4 or 5.
3. Subject requires primary treatment of up to two de novo or restenotic (treated with
prior PTA) infrapopliteal lesions.
4. Subject must be at least 18 years of age.
5. Female subject of childbearing potential should not be pregnant and must be on birth
control.
Note: Female subjects of child-bearing potential must have a negative pregnancy test done
within 7 days prior to the index procedure per site standard test.
Anatomic Inclusion Criteria:
1. Up to two native infrapopliteal lesions, each lesion located in separate
infrapopliteal vessel in the same limb. Restenotic (from prior PTA) lesions are
allowed.
1. Lesion must be located in the proximal 2/3 of native infrapopliteal vessels, with
vessel diameter of = 2.5 mm and = 4.00 mm by investigator visual assessment.
2. Total scaffold length to completely cover/treat a target lesion must not exceed
170 mm (total everolimus drug dose of 1790 µg).
3. The total scaffold length among all target lesions must not exceed 170 mm.
4. The target vessel cannot have any other angiographic significant lesions (=50%).
5. Tandem lesions are allowed if they are < 3 cm apart and the total scaffold length
used to cover the entire diseased segment is = 170 mm. Each tandem lesion is
considered one lesion.
2. Target lesion(s) must have = 70% stenosis, per visual assessment at the time of the
procedure. If needed, quantitative imaging (angiography, IVUS, and/or OCT) can be used
to aid accurate sizing of the vessels.
3. The distal margin of the target lesion must be located = 10 cm proximal to the
proximal margin of the ankle mortise. The vessel segment distal to the target lesion
must be patent all the way to the ankle, with no significant lesion (= 50% stenosis).
4. Significant lesion (= 50% stenosis) in the inflow artery(ies) must be treated
successfully (as per physician's assessment of the angiography) through standard of
care prior to the treatment of the target lesion. Treatment can be done within the
same trial procedure.
5. Non-target lesion(s) (if applicable) must be located in separate infrapopliteal
vessel(s) from the target lesion, and suitable to be treated per institution standard
of care.
6. Guidewire must cross the target lesion successfully. Crossing in an antegrade fashion
is preferred, but retrograde crossing may be used. However, the treatment must be
delivered antegrade.
Exclusion Criteria:
General Exclusion Criteria:
1. Subject is currently participating in another clinical investigation that has not yet
completed its primary endpoint.
2. Pregnant or nursing subjects and those who plan pregnancy during the clinical
investigation follow-up period.
3. Presence of other anatomic or comorbid conditions, or other medical, social, or
psychological conditions that, in the investigator's opinion, could limit the
subject's ability to participate in the clinical investigation or to comply with
follow-up requirements.
4. Incapacitated individuals, defined as persons who are mentally ill, mentally
handicapped, or individuals without legal authority, are excluded from the study
population.
5. Subject has had any amputation to the ipsilateral extremity other than the toe or
forefoot, or subject has had major amputation to the contralateral extremity < 1 year
prior to index procedure and is not independently ambulating.
6. Subject has known hypersensitivity or contraindication to device material and its
degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and
cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot
be adequately pre-medicated. Subject has a known contrast sensitivity that cannot be
adequately pre-medicated.
7. Subject has known allergic reaction, hypersensitivity or contraindication to aspirin;
or to ADP antagonists such clopidogrel, prasugrel or ticagrelor; or to anticoagulants
such as heparin or bivalirudin, and therefore cannot be adequately treated with study
medications. Subject with planned surgery or procedure necessitating discontinuation
of antiplatelet medications, within 12 months after index procedure. Planned
amputation that will necessitate discontinuation of antiplatelet medications is
allowed.
8. Subject has life expectancy = 1 year.
9. Subject has had a stroke within the previous 3 months with residual Rankin score of =
2.
10. Subject has renal insufficiency as defined as an estimated GFR < 30 ml/min per
1.73m^2.
11. Subject is currently on dialysis.
12. Subject has platelet count < 100,000 cells/mm^3 or > 700,000 cells/mm^3, a WBC < 3,000
cells/mm^3, or hemoglobin < 9.0 g/dl.
13. Subject has known serious immunosuppressive disease (e.g., human immunodeficiency
virus), or has severe autoimmune disease, that requires chronic immunosuppressive
therapy (e.g., systemic lupus erythematosus, etc.), or subject is receiving
immunosuppression therapy for other conditions. Subjects treated for HIV (Human
Immunodeficiency Virus) and who have undetectable viral load, such that their immune
system is not considered compromised, are eligible.
14. Subject has Body Mass Index (BMI) <18.
15. Subject is receiving or scheduled to receive anticancer therapy for malignancy within
6 months prior to index procedure or within 1 year after the procedure. Patients
taking medications classified as chemotherapy but who have been in remission for at
least 6 months are eligible.
16. Subject has coagulation disorder that increases the risk of arterial thrombosis.
Subjects with deep vein thrombosis and disorders that increase the risk of deep vein
thrombosis can be included in the study.
17. Subject who requires thrombolysis as a primary treatment modality or requires other
treatment for acute limb ischemia of the target limb.
18. Subject has previously had, or requires surgical revascularization involving any
vessel of the ipsilateral extremity. Prior femoropopliteal or aortobifemoral bypass is
allowed. Any bypass to the tibial arteries is not allowed.
19. Subject has signs or symptoms of advanced limb infection or septicemia (fever > 38.5,
WBC > 15,000 cells/microliter, hypotension) at the time of assessment. Osteomyelitis
of the phalanges or metatarsal heads (as described in exclusion criteria #21a) or
cellulitis of the foot amenable to treatment with IV antibiotics at the time of
revascularization is acceptable.
20. Subject is bedridden or unable to walk (with assistance is acceptable). Subjects in
wheelchair who are able to mobilize on their own can be enrolled.
21. Subject with extensive tissue loss salvageable only with complex foot reconstruction
or non-traditional transmetatarsal amputations. This includes subjects with:
1. Osteomyelitis that extends proximal to the metatarsal heads. Osteomyelitis
limited to the phalanges or metatarsal heads is acceptable for enrollment.
2. Gangrene involving the plantar skin of the forefoot, midfoot, or heel.
3. Deep ulcer or large shallow ulcer (> 3 cm) involving the plantar skin of the
forefoot, midfoot, or heel.
4. Full thickness heel ulcer with/without calcaneal involvement.
5. Any wound with calcaneal bone involvement.
6. Wounds that are deemed to be neuropathic or non-ischemic in nature.
7. Wounds that would require flap coverage or complex wound management for large
soft tissue defect.
8. Full thickness wounds on the dorsum of the foot with exposed tendon or bone.
22. Subject is unable or unwilling to provide written consent prior to enrollment.
23. Subject has active symptoms and/or a positive test result of COVID-19 or other rapidly
spreading novel infectious agent within the prior 2 months.
Anatomic Exclusion Criteria:
1. Lesions with severe calcification, in which there is a high likelihood that successful
pre-dilatation cannot be achieved.
2. Lesion that has prior metallic stent implant.
3. Significant (= 50% stenosis) lesion in a distal outflow artery that would be perfused
by the target vessel and that requires treatment at the time of the index procedure.
4. Subject has had or will require treatment in any vessel with an everolimus drug-coated
or drug-eluting device < 30 days pre-study procedure, or during the index procedure,
such that the cumulative (Esprit BTK plus everolimus-eluting device) everolimus drug
dose exceeds 1790 µg.
5. Target or (if applicable) non-target vessel contains visible thrombus as indicated in
the angiographic images.
6. Subject has angiographic evidence of thromboembolism or atheroembolism in the
ipsilateral extremity. (Pre- and post-angiographic imaging must confirm the absence of
emboli in the distal anatomy).
7. Unsuccessfully treated proximal inflow limiting arterial stenosis or inflow-limiting
arterial lesions left untreated.
8. No angiographic evidence of a patent pedal artery.
9. Target or (if applicable) non-target lesion location requiring bifurcation treatment
method that requires scaffolding of both branches (provisional treatment, without
intention of scaffolding both branches is acceptable).
10. Aneurysm in the iliac, common femoral, superficial femoral, popliteal or target artery
of the ipsilateral extremity.
11. Visual assessment of the target lesion suggests that the investigator is unable to
pre-dilate the lesion according to the vessel diameter.
12. Target lesion has a high probability that atherectomy will be required at the time of
index procedure for treatment of the target vessel.
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