Overview

Lower-Limb Adventitial Infusion of DexaMethasone Via Bullfrog to Reduce Occurrence of Restenosis After Percutaneous Transluminal Angioplasty Revascularization

Status:
Recruiting
Trial end date:
2020-08-01
Target enrollment:
0
Participant gender:
All
Summary
This is a prospective, multi-center, randomized pilot study to document the effects of adventitial delivery of dexamethasone after balloon angioplasty of lesions below the knee in symptomatic patients with critical limb ischemia (CLI).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mercator MedSystems, Inc.
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Criteria
Inclusion Criteria:

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)

Exclusion Criteria:

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 a failure to successfully treat
and obtain a <30% residual stenosis

- Index lesion length is >30 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-index lesions) >50 cm

- Lesions revascularized during the index case but untreated by Bullfrog

- Use of alternative therapy, e.g. atherectomy, laser, or 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