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Clinical Trial 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).


Clinical Trial Description

This is a prospective, multi-center, randomized pilot study to document the effects of adventitial delivery of dexamethasone sodium phosphate injection (4 mg/mL) after balloon angioplasty of lesions below the knee in symptomatic patients with critical limb ischemia (CLI). Up to 120 patients (60 treatment and 60 control), including up to 20 Rutherford 6 patients (10 treatment and 10 control) at up to 30 sites in Europe and the United States. This study will assess the safety and effectiveness of Bullfrog Micro-Infusion Device adventitial deposition of dexamethasone in reducing inflammation and restenosis in patients with clinical evidence of chronic critical limb ischemia with an angiographically significant lesion in the infrapopliteal crural vessels. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02479555
Study type Interventional
Source Mercator MedSystems, Inc.
Contact Kristen L. Poole, PhD
Phone 510-564-7761
Email kpoole@mercatormed.com
Status Recruiting
Phase Phase 2
Start date January 2016
Completion date August 2020

See also
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Active, not recruiting NCT02908035 - Temsirolimus Adventitial Delivery to Improve Angiographic Outcomes Below the Knee (TANGO) Phase 2
Active, not recruiting NCT02479620 - Lower-Limb Adventitial Infusion of DexaMethasone Via Bullfrog to Reduce Occurrence of Restenosis After Atherectomy (ATX)-Based Revascularization Phase 2
Not yet recruiting NCT03847597 - Histological and Imaging Assessment of the Structural Characteristics of the Femoro-popliteal Arterial Segment
Recruiting NCT06416644 - The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry) N/A