Clinical Trials Directory

Trials / Completed

CompletedNCT02097082

Treatment of SFA Lesions With 480 Biomedical STANZA™ Drug-Eluting Resorbable Scaffold (DRS) System

An Evaluation of the 480 Biomedical STANZA™ Drug-Eluting Resorbable Scaffold (DRS) System in the Treatment of de Novo SFA Lesions

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
28 (actual)
Sponsor
480 Biomedical · Industry
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

An evaluation of the safety and performance of the STANZA Drug-eluting Resorbable Scaffold (DRS) system for the treatment of patients with obstructive superficial femoral artery disease.

Detailed description

The STANZA DRS system is comprised of a controlled release paclitaxel-eluting bioresorbable scaffold and a delivery system used in the treatment of superficial femoral artery disease.

Conditions

Interventions

TypeNameDescription
DEVICESTANZA Drug-eluting resorbable Scaffold

Timeline

Start date
2013-10-01
Primary completion
2016-03-30
Completion
2017-05-01
First posted
2014-03-26
Last updated
2019-09-06

Locations

9 sites across 4 countries: Austria, Germany, New Zealand, Switzerland

Source: ClinicalTrials.gov record NCT02097082. Inclusion in this directory is not an endorsement.