Lower-Limb Adventitial Infusion of DexaMethasone via Bullfrog to Reduce Occurrence of Restenosis after Atherectomy (ATX)-Based Revascularization

This is a prospective, multi-center, randomized pilot study to document the effects of adventitial delivery of dexamethasone after atherectomy-based revascularizations of lesions below the knee in symptomatic patients with critical limb ischemia (CLI).

Key Inclusion Criteria:

1. Age ≥18 years
2. Patient or patient's legal representative have been informed of the nature of the study, agrees to participate and has signed an IRB/EC approved consent form
3. Female patients of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation
4. Patient has documented chronic Critical Limb Ischemia (CLI) in the target limb from the popliteal artery to the ankle joint prior to the study procedure with Rutherford Category 4, 5 or 6
5. Life expectancy >1 year in the Investigator's opinion
Angiographic Criteria:

6. Successful revascularization of the TL with less than 30% residual stenosis, run-off down to the foot and direct in-line flow to any foot wound
7. Reference vessel(s) diameter ≥2 mm
8. Single or multiple atherosclerotic lesion ≥70% in at least one infrapopliteal crural target vessel including the tibioperoneal trunk that totals up to 30 cm in length (with no greater than 5 cm length of contiguous intervening normal artery), with possible extension into the popliteal artery distal to the center of the knee joint space (the P3 segment)

See clinicaltrials.gov for full details.
Phase II
Heart and Vascular, All Other
Interventional Cardiology
Ethan Korngold MD
Heather Aiona
  • Providence Portland Medical Center
  • Providence St. Vincent Medical Center