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

Summary

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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 injec...

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.

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