MedTrace Logo

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

NCT02479620 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-02-19

No results posted yet for this study

Summary

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).

Conditions

  • Chronic Limb Ischemia

Interventions

DRUG

Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL

Following atherecomy-based revascularization, Investigators will be unblinded to assignment and will treat only patients assigned to the treatment arm with the Bullfrog delivery of dexamethasone.

Sponsors & Collaborators

  • Mercator MedSystems, Inc.

    lead INDUSTRY

Principal Investigators

  • George Adams, MD · REX Hospital, University of North Carolina Healthcare

  • Donald Jacobs, MD · Saint Louis University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2019-11-30
Completion
2020-03-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02479620 on ClinicalTrials.gov