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Safety and Efficacy of the Combo Bio-engineered Sirolimus-eluting Stent Versus the Nano Polymer-free Sirolimus-eluting Stent in the Treatment of Patients With de Novo Stenotic Lesions

NCT02542007 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2021-09-09

No results posted yet for this study

Summary

To evaluate the safety, efficacy and deliverability of the Combo bio-engineered sirolimus-eluting stent versus the Nano polymer-free sirolimus- eluting stents in the treatment of patients with de novo stenotic lesions of native coronary artery.

Conditions

  • Coronary Arteriosclerosis

Interventions

DEVICE

OrbusNeich Combo stent™

The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.

DEVICE

sirolimus-eluting stent system

Sponsors & Collaborators

  • CCRF Inc., Beijing, China

    collaborator INDUSTRY

  • OrbusNeich Medical (Shenzhen), Co. Ltd.

    collaborator INDUSTRY

  • OrbusNeich

    lead INDUSTRY

Principal Investigators

  • Tao Ling, M.D. · The First Affiliated Hospital of the Fourth Medical University

  • Xu Bo, M.D · The Secondary Affiliated Hospital of Harbin University

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
2015-05-31
Primary Completion
2017-05-27
Completion
2021-06-10

Countries

  • China

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 NCT02542007 on ClinicalTrials.gov