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

NCT ID: NCT02448524

Last Updated: 2020-09-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 428 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2022-11-30

Brief 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.

Detailed 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.

Conditions

Coronary Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MiStentTM

MiStentTM coronary drug eluting stent (MiStent SES) consists of four parts: a bare-metal stent (BMS), a delivery system, resorbable polymer coating and anti-proliferative drug (sirolimus).

Group Type: EXPERIMENTAL

MiStent

Intervention Type: DEVICE

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).

TIVOLI

TIVOLI stent is a mature and fully degradable coating on a cobalt-chromium alloy drug-eluting stent on the market, findings of four years fully demonstrated the efficacy and safety of sirolimus-coated TIVOLI stent.

Group Type: ACTIVE_COMPARATOR

TIVOLI

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Stable and unstable angina pectoris (AP), old myocardial infarction (OMI), or confirmed evidence of myocardial ischemia;
• Primary in situ coronary artery lesions (up to two target lesions and up to 2 stents per 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 accept angiographic and clinical follow-up.

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), restenosis in-stent and three-vessel disease that need to be treated;
• Severe calcified lesions for which balloon pre-dilation is expected to be unsuccessful;
• 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 the following year;
• Subjects with bleeding tendency or coagulation disorder or PCI contraindications and / or anticoagulant therapy contraindications or who have not tolerated dual antiplatelet treatment 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 1 year;
• 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 upper limit of normal; eGFR <30ml/min);
• Patients participating in any other clinical trial and who have not completed follow-up to the primary endpoint;
• Study subjects with poor compliance judged by investigators, with poor possibility to complete study in accordance with requirements.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hefei Life Science Medical Instruments Co. Ltd.

UNKNOWN

Sponsor Role: collaborator

Giant Med-Pharma Services Inc.

INDUSTRY

Sponsor Role: collaborator

CCRF Consulting Co., Ltd.

OTHER

Sponsor Role: collaborator

Micell Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yaling Han, MD

Role: PRINCIPAL_INVESTIGATOR

The General Hospital of Shenyang Military Region

Locations

The First Hospital of Jilin University

Changchun, , China

The Second Xiangya Hospital of Central South University

Changsha, , China

The First Hospital of Lanzhou University

Lanzhou, , China

Shanghai Ninth People's Hospital

Shanghai, , China

West China Hospital, Sichuan University

Sichuan, , China

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

The First Affiliated Hospital of Baotou University

Baotou, Inner Mongolia, China

Inner Mongolia People'S Hospital

Hohhot, Inner Mongolia, China

The First Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Affiliated Hospital of Xi'An Jiaotong University

Xi'an, Shaanxi, China

Sir Run Run Shaw Hospital School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

The General Hospital of Shenyang Military Region

Area of Shenyang, , China

Fu Wai Hospital, National Center for Cardiovascular Disease

Beijing, , China

The Second Hospital of Shanxi Medical University

Taiyuan, , China

TEDA International Cardiovascular Hospital

Tianjin, , China

Countries

China

Other Identifiers

MiStent01

Identifier Type: -

Identifier Source: org_study_id