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ARTDIVA Study : First in Man Safety Evaluation of the ART18Z Bioresorbable Stent

NCT01761578 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-01-14

No results posted yet for this study

Summary

This prospective, multicentre, open labeled, single arm, first in man interventional investigation aims to evaluate the safety of the ART18Z bioresorbable stent for the treatment of patients with single de novo lesion of a native coronary artery with mandatory balloon predilatation.

Conditions

Interventions

DEVICE

ART18Z Bioresorbable stent

The drug free fully bioresorbable coronary stent ART18Z is a balloon expandable poly lactic acid stent.

Sponsors & Collaborators

  • Arterial Remodeling Technologies

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-06-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

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 NCT01761578 on ClinicalTrials.gov