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

Status unconfirmed · Phase 2

Conditions studied: Chronic Limb Ischemia

In brief

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 facts

Study ID

NCT02479620

Run by

Mercator MedSystems, Inc.

People needed

120

Starts

2016-06-01

Expected to finish

2020-03-01

Last updated by the study team

2020-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Screening Criteria:
• Age ≥18 years
• 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
• 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
• 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
• Life expectancy >1 year in the Investigator's opinion
• Angiographic Criteria:
• 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
• Reference vessel(s) diameter ≥2 mm
• 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)

You may not qualify if…

• Screening Criteria:
• Patient unwilling or unlikely to comply with visit schedule
• Planned major index limb amputation
• Active foot infection; however, osteomyelitis in the toes or mild cellulitis around the perimeter of gangrene or small ulcers are not exclusions, but osteomyelitis of the metatarsal or more proximal region would be exclusionary
• Inability to receive study medications
• Estimated glomerular filtration rate (eGFR) less than 30 mL/min, except for patients with end stage renal disease on chronic hemodialysis
• Stage 3 (per SVS WIfI classification) or worse heel ulcers or heel ulcers that are determined to be primarily neuropathic in nature
• Angiographic/Procedural Criteria:
• Hemodynamically significant inflow lesion (≥50% DS) or occlusion in the ipsilateral iliac, SFA, or popliteal arteries in which there is failure to successfully treat and obtain a <30% residual stenosis
• Target lesion length is >25 cm as measured from proximal normal vessel to distal normal vessel
• Total length of lesions treated during the case (including target lesion, inflow lesions, and other non-target lesions) >25 cm
• Lesions revascularized during the index case but untreated by Bullfrog
• Use of alternative therapy, e.g. radiation therapy, as part of the index lesion treatment, or use of any drug eluting stents (DES) or drug-eluting balloon/drug-coated balloons (DEB/DCB) for treatment of any infra-inguinal lesions during the study procedure or during the initial six-month follow up period
• Previously implanted stent in the TL(s)
• Aneurysm in the target vessel
• Acute thrombus in the target limb
• Failure to cross the TL with a guide wire; however, subintimal wire crossing is allowed
• Heavy eccentric or concentric calcification at index lesion, which in the judgment of the investigator would prevent penetration of the Micro-Infusion Device needle through the vessel wall

Where it is running

• Arkansas Heart Hospital — Little Rock, Arkansas, United States
• Denver Veterans Administration Hospital — Denver, Colorado, United States
• Mid-Michigan Heart & Vascular — Saginaw, Michigan, United States
• Hattiesburg Clinic — Hattiesburg, Mississippi, United States
• St.Louis University Hospital — St Louis, Missouri, United States
• Holy Name Medical Center — Teaneck, New Jersey, United States
• UNC Health Care - Rex Hospital — Raleigh, North Carolina, United States
• Sanford Research — Sioux Falls, South Dakota, United States
• Tennova - Turkey Creek Medical Center — Knoxville, Tennessee, United States
• Mission Research Institute (New Braunfels Cardiology - GRMC) — New Braunfels, Texas, United States

Full record on ClinicalTrials.gov

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