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

NCT02360423 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 430

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 and the RESOLUTE zotarolimus-eluting stent in the treatment of patients with de novo coronary artery lesions.

Conditions

Interventions

DEVICE

CRE8 sirolimus-eluting stent

The CRE8 stent is a flexible implantable device that can be expanded using a PTCA catheter. The stent is made of Cobalt chromium alloy and is coated with i-carbofilm.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.

DEVICE

RESOLUTE zotarolimus-eluting stent

The RESOLUTE stent is a flexible implantable device that can be expanded using a PTCA catheter. The stent is made of Cobalt chromium tungsten alloy. It has been approved by CFDA in 2009 and commercially available in Chinese market

Sponsors & Collaborators

  • CID S.p.A.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-10-31
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 NCT02360423 on ClinicalTrials.gov