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Effectiveness of Adventitial Dexamethasone in Peripheral Artery Disease

NCT01983449 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2018-03-08

No results posted yet for this study

Summary

To assess the safety and effectiveness of adventitial deposition of the Study Drug in reducing inflammation and restenosis in patients with clinical evidence of claudication or critical limb ischemia and an angiographically significant lesion in the superficial femoral and/or popliteal arteries.

Study Drug and Dose: Dexamethasone Sodium Phosphate Injection, USP, 4 mg/ml, with dilute contrast (17%) administered to the adventitia in a dose of 1.6 mg per cm of desired vessel treatment length.

Conditions

  • Peripheral Arterial Diseases

Interventions

DRUG

Dexamethasone Sodium Phosphate Injection, USP

Adventitial infusion of dexamethasone after angioplasty or atherectomy-based revascularization of the superficial femoral or popliteal artery.

Sponsors & Collaborators

  • Mercator MedSystems, Inc.

    lead INDUSTRY

Principal Investigators

  • Mahmood Razavi, MD · St. Joseph's Vascular Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-12-31
Completion
2018-01-31

Countries

  • United States

Study Locations

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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 NCT01983449 on ClinicalTrials.gov