Peripheral Arterial Disease
Conditions
Keywords
Peripheral Arterial Disease, Femoral popliteal lesions
Brief summary
The purpose of this study is to test if dexamethasone, an anti-inflammatory medication approved by the US Food and Drug Administration (FDA), can be injected safely into the tissue around the blood vessel wall at the time of an angioplasty or atherectomy.
Detailed description
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.
Interventions
PROCEDUREAdministration of dexamethasone to SFA/popliteal adventitia
Following a balloon angioplasty or atherectomy of a stenotic TASC II A, B, or C lesion in the superficial femoral or popliteal artery, a Bullfrog Micro-Infusion Catheter will be used to infuse 0.96 mg dexamethasone per cm arterial lesion.
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Outcome Measures: | 30 days | Freedom from death, vessel dissection, thrombosis or extravasation at 30 days post-procedure. |
| Effectiveness Outcome Measures: | 6 months | Freedom from Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 6 months post-procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Outcome Measures: | 24 months | Freedom from death, stroke, myocardial infarction, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel |
Countries
United States
Outcome results
None listed