Peripheral Arterial Disease Clinical Trial
Official title:
Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization
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.
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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