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Clinical Trial on the Efficacy and Safety of Sirolimus-Eluting Stent (MiStent® System)

NCT02448524 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 428

Last updated 2020-09-04

No results posted yet for this study

Summary

* To evaluate the safety and efficacy of MiStent drug (sirolimus)-eluting stent system in the treatment of coronary heart disease (CHD) in patients with primary in situ CHD (de novo);
* To evaluate operating performance of the MiStent drug (sirolimus)-eluting coronary stent system.

Conditions

Interventions

DEVICE

MiStent

Primary in situ coronary artery disease patients (all patients enrolled with a maximum of two target lesions in different blood vessels and maximum of 2 stents per lesion. Lesions with reference diameter of 2.5mm-3.5mm (by visual measurement) and with length ≤40mm (by visual measurement).

DEVICE

TIVOLI

Primary in situ coronary artery disease patients (all patients enrolled with a maximum of two target lesions in different blood vessels and maximum of 2 stents per lesion. Lesions with reference diameter of 2.5mm-3.5mm (by visual measurement) and with length ≤40mm (by visual measurement).

Sponsors & Collaborators

  • Hefei Life Science Medical Instruments Co. Ltd.

    collaborator UNKNOWN

  • Giant Med-Pharma Services Inc.

    collaborator INDUSTRY

  • CCRF Consulting Co., Ltd.

    collaborator OTHER

  • Micell Technologies

    lead INDUSTRY

Principal Investigators

  • Yaling Han, MD · The General Hospital of Shenyang Military Region

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2018-11-30
Completion
2022-11-30

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 NCT02448524 on ClinicalTrials.gov