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

Chronic Limb Ischemia Clinical Trial

Official title:
LIMBO-PTA: Lower-Limb Adventitial Infusion of DexaMethasone Via Bullfrog to Reduce Occurrence of Restenosis After Percutaneous Transluminal Angioplasty Revascularization

Status Recruiting

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

Clinical Trial Details

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

View Details

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