MedTrace Logo

Safety and Efficacy of the CRE8 Sirolimus-Eluting Stent for the Treatment of De Novo Coronary Artery Lesions

NCT02360709 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2015-03-25

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, efficacy and deliverability of the CRE8 sirolimus-eluting stent system in the treatment of patients with de novo coronary artery lesions.

Conditions

Interventions

DEVICE

CRE8 sirolimus-eluting stent

The CRE8 stent system consists of a sirolimus eluting coronary stent firmly held on the distal end of a semicompliant balloon catheter. This stent is made of cobalt chromium alloy and is coated with a thin carbon film.The outer surface of the stent has dedicated grooves for containing the pharmaceutical formulation, which is composed of the drug sirolimus and a mixture of long chain fatty acids.

Sponsors & Collaborators

  • CID S.p.A.

    lead INDUSTRY

Principal Investigators

  • Shubin Qiao, MD · Fu Wai Hospital, National Center for Cardiovasular disease

Eligibility

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

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2017-01-31
Completion
2021-04-30

Countries

  • China

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 NCT02360709 on ClinicalTrials.gov