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LIMBO-ATX: 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).
Details
| Lead sponsor | Mercator MedSystems, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 120 |
| Start date | 2016-06 |
| Completion | 2020-03 |
Conditions
- Chronic Limb Ischemia
Interventions
- Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL
Primary outcomes
- Freedom from MALE — Up to 6 Months following the procedure
Freedom from major adverse limb event (MALE) within 6 months. - Freedom from CD-TLR — Up to 6 Months following the procedure
Freedom from clinically driven target lesion revascularization (CD-TLR) within 6 months. - Composite clinical safety by freedom from adverse events including death, MALE, major unplanned amputation, or CD-TLR. — Up to 6 Months following the procedure
Freedom from composite of death within 30 days from the index procedure, MALE, major unplanned amputation or CD-TLR within 6 months. - TVAL% change from post-procedure — 6 Months following the procedure
Transverse-view vessel area loss percentage (TVAL%) of the target lesion at 6 months by quantitative vascular angiography (QVA) or prior to any CD-TLR of the target lesion before 6 months
Countries
United States