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

Last updated: September 3, 2020
Sponsor: Micell Technologies
Overall Status: Active - Not Recruiting

Phase

3

Condition

Cardiac Disease

Hypercholesterolemia

Cardiovascular Disease

Treatment

N/A

Clinical Study ID

NCT02448524
MiStent01
  • Ages 18-75
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Stable and unstable angina pectoris (AP), old myocardial infarction (OMI), orconfirmed evidence of myocardial ischemia;

  • Primary in situ coronary artery lesions (up to two target lesions and up to 2 stentsper lesion);

  • Visual target lesion length ≤40mm;

  • Visual reference vessel diameter of 2.5-3.5mm;

  • Visual diameter stenosis ≥70%;

  • Patients with indications for coronary artery bypass surgery (CABG);

  • Subjects participate voluntarily and signed an informed consent willing to acceptangiographic and clinical follow-up.

Exclusion

Exclusion Criteria:

  • Acute myocardial infarction (AMI) occurred within 7 days prior to the procedure;post-MI complicated with elevated levels of cardiac enzymes (CK-MB, cTNT / I);

  • CTO (TIMI-0) lesions, left main lesions, ostial lesions,bypass graft lesions,bifurcation lesions (lateral side branch reference vessel diameter≥2.5mm), restenosisin-stent and three-vessel disease that need to be treated;

  • Severe calcified lesions for which balloon pre-dilation is expected to beunsuccessful;

  • Tortuous lesions that render stent crossing difficult;

  • NYHA class≥III or left ventricular ejection fraction <40%;

  • Implantation of other stents in the past year;

  • Pregnant or breast-feeding patients or patients planning to get pregnant within thefollowing year;

  • Subjects with bleeding tendency or coagulation disorder or PCI contraindications and /or anticoagulant therapy contraindications or who have not tolerated dual antiplatelettreatment within a year to date;

  • Presence of other diseases (such as cancer, malignancies, congestive heart failure,organ transplantation or candidate for it) or history of substance abuse (alcohol,cocaine, heroin, etc.), poor protocol compliance or life expectancy of less than 1year;

  • Allergic to one of following: aspirin, heparin, clopidogrel, sirolimus (rapamycin),PLGA polymers, contrast agents and metal;

  • Severe liver and kidney dysfunction (ALT or AST level 3 times greater than the upperlimit of normal; eGFR <30ml/min);

  • Patients participating in any other clinical trial and who have not completedfollow-up to the primary endpoint;

  • Study subjects with poor compliance judged by investigators, with poor possibility tocomplete study in accordance with requirements.

Study Design

Total Participants: 428
Study Start date:
July 01, 2015
Estimated Completion Date:
November 30, 2022

Study Description

  • The study will enroll a total of 428 cases of 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. If more stents are needed for implantation, stents with the same brand are required, and mixing brands is not allowed for each patient except for salvage with implantation of other brand of stents.)

  • Lesions with reference diameter of 2.5mm-3.5mm (by visual measurement) and with length ≤40mm (by visual measurement) will be selected, subjects meeting the inclusion and exclusion criteria and who agree to participate will be enrolled.

  • Prospective, single-blinded, multi-center, randomized, controlled clinical trial;

  • Patients with in situ primary CHD;

  • Clinical sites: up to 18; patients will be enrolled in a 1:1 ratio (i.e., 214 cases enrolled into each group, the MiStent stent group and TIVOLI stent group);

  • Clinical follow-up time points: 1 month, 6 months, 9 months, 12 months and yearly at 2-5 years post index procedure;

  • Angiographic follow-up at 9 months post index procedure; in-stent late lumen loss measured by quantitative coronary angiography (QCA) will be used as the primary efficacy endpoint for product evaluation;

  • In this trial, the collection, collation, statistical analysis and adjudication of all relevant clinical and angiographic data will be conducted by an independent coronary angiography core laboratory (CCRF Medical Technology Co., Ltd.), data management and statistical center, clinical events committee and clinical audit agency. All patients will be followed up for 5 years (by telephone or outpatient form), and the incidence of adverse events will be recorded to allow a more accurate and reliable evaluation of the long-term safety of the MiStentTM drug (sirolimus) eluting coronary stent system.

Connect with a study center

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan
    China

    Site Not Available

  • The First Affiliated Hospital of Baotou University

    Baotou, Inner Mongolia
    China

    Site Not Available

  • Inner Mongolia People'S Hospital

    Hohhot, Inner Mongolia
    China

    Site Not Available

  • The First Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'An Jiaotong University

    Xi'an, Shaanxi
    China

    Site Not Available

  • Sir Run Run Shaw Hospital School of Medicine, Zhejiang University

    Hangzhou, Zhejiang
    China

    Site Not Available

  • The General Hospital of Shenyang Military Region

    Area Of Shenyang,
    China

    Site Not Available

  • Fu Wai Hospital, National Center for Cardiovascular Disease

    Beijing,
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun,
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha,
    China

    Site Not Available

  • Guangdong General Hospital

    Guangdong,
    China

    Site Not Available

  • Anhui Provincial Hospital

    Hefei,
    China

    Site Not Available

  • Daqing General Hospital of Oilfield

    Honggang,
    China

    Site Not Available

  • The First Hospital of Lanzhou University

    Lanzhou,
    China

    Site Not Available

  • Zhongda Hospital, Southeast University

    Nanjing,
    China

    Site Not Available

  • Shanghai Ninth People's Hospital

    Shanghai,
    China

    Site Not Available

  • The General Hospital of Shenyang Military Region

    Shenyang,
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Sichuan,
    China

    Site Not Available

  • The Second Hospital of Shanxi Medical University

    Taiyuan,
    China

    Site Not Available

  • TEDA International Cardiovascular Hospital

    Tianjin,
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou,
    China

    Site Not Available

  • Wuhan Asia Heart Hospital

    Wuhan,
    China

    Site Not Available

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