Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization

This is an investigator-initiated, single-arm, external pilot study to assess the safety and
feasibility of perivascular administration of dexamethasone following endovascular
superficial femoral and popliteal artery angioplasty or atherectomy.

Although dexamethasone is approved by the FDA for injection into blood, skin or joints, it
has not been approved by the FDA for injection around blood vessels. The investigators want
to find out if this procedure helps prevent re-narrowing of the blood vessel after
angioplasty or atherectomy. The dexamethasone will be injected with a Bullfrog®
Micro-Infusion catheter, which is an FDA-approved device for injecting medications into
tissues around the blood vessel wall. The Bullfrog® Micro-Infusion catheter is similar to
other balloon tipped catheters except that it contains a microneedle covered by a fold of
semi-rigid balloon. Once the balloon is inflated, the microneedle is uncovered and a
medication can be injected into the tissue around the blood vessel.

Inclusion Criteria:

- Patient is > 40 years and < 80 years of age

- Patient has severe, lifestyle-limiting claudication or critical limb ischemia
(Rutherford classification 3-6)

- Patient has TASC II A, B or C disease, SFA revascularization is preferred over medical
management, and endovascular approach is preferred revascularization strategy

- Patient has a resting ABI of <0.9 or an abnormal treadmill ABI. Patients with
incompressible arteries must have a TBI <0.8

- Patient has at least 1 infra-popliteal run-off vessel with patency to the ankle
without a >50% stenosis

- Successful crossing of the lesion with guidewire and successful atherectomy or
angioplasty with residual stenosis <30% as compared to the reference vessels

- Atherectomy procedure does not result in embolization, arteriovenous fistula or
perforation

- Patient agrees to return for a clinical assessment duplex ultrasound at 1, 3, 6, 9, 12
and 24 months (routine clinical care)

Exclusion Criteria:

- Patient is simultaneously participating in another investigational drug or device
study

- Patient is pregnant or breast-feeding

- Patient has cancer, autoimmune disease, bone marrow or organ transplant, or other
concurrent medical illness requiring immunosuppressive therapy

- Patient has end-stage renal disease and chronic kidney disease (eGFR<30)

- Patient has an active infection

- Patient has a known hypersensitivity or contraindication to heparin, contrast agents,
excipients of Dexamethasone Sodium Phosphate Injection, USP, dexamethasone, or other
glucocorticoids

- Patient has a life expectancy of less than one year