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

NCT02448524 | Unknown Phase 3 DMC

• 1 other identifier: MiStent01
• Study Type: interventional
• Target: 428
• Locations: 1 country
• Sites: 16

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.

Conditions

Coronary Heart Disease

Keywords

Treatment; patients; primary in situ CHD (de novo) lesions

Outcome Measures

Primary Outcomes (1)

• In-stent late lumen loss (LLL)

  Late lumen loss is the difference in millimeters between the diameter of a stented segment post-procedure compared with the follow-up angiogram at nine months

  9 months post index procedure

Secondary Outcomes (6)

• Success rate of stent implantation (including device success, lesion success and clinical success);

  Baseline

• Restenosis rate in-stent, at proximal and distal edges of the stent and in-lesion segments; and late lumen loss and percent diameter stenosis in lesion segments

  9 months

• Device-related clinical cardiovascular composite endpoints post index procedure, including cardiac death, target vessel myocardial infarction and clinical symptoms driven target lesion revascularization (i.e., target lesion failure [TLF])

  30 days, 6 months, 12 months, and 2-5 years

• Patient-related clinical cardiovascular composite endpoints post index procedure, including all-cause death (cardiac and non-cardiac), nonfatal myocardial infarction and any revascularization

  30 days, 6 months, 12 months and 2-5 years

• Incidence of ARC-defined stent thrombosis (definite, probable, possible stent thrombosis at early, late and very late periods)

  30 days, 6 months, 12 months and 2-5 years

Study Arms (2)

MiStentTM

EXPERIMENTAL

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).

Device: MiStent

TIVOLI

ACTIVE COMPARATOR

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.

Device: TIVOLI

Interventions

MiStent 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).

MiStentTM

TIVOLI 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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Micell Technologies: lead
• Hefei Life Science Medical Instruments Co. Ltd.: collaborator
• Giant Med-Pharma Services Inc.: collaborator
• CCRF Consulting Co., Ltd.: collaborator

Study Sites (16)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

The First Affiliated Hospital of Baotou University

Baotou, Inner Mongolia, China

Location

Inner Mongolia People'S Hospital

Hohhot, Inner Mongolia, China

Location

The First Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

The First Affiliated Hospital of Xi'An Jiaotong University

Xi'an, Shaanxi, China

Location

Sir Run Run Shaw Hospital School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Location

The General Hospital of Shenyang Military Region

Area of Shenyang, China

Location

Fu Wai Hospital, National Center for Cardiovascular Disease

Beijing, China

Location

The First Hospital of Jilin University

Changchun, China

Location

The Second Xiangya Hospital of Central South University

Changsha, China

Location

The First Hospital of Lanzhou University

Lanzhou, China

Location

Shanghai Ninth People's Hospital

Shanghai, China

Location

West China Hospital, Sichuan University

Sichuan, China

Location

The Second Hospital of Shanxi Medical University

Taiyuan, China

Location

TEDA International Cardiovascular Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Yaling Han, MD

  The General Hospital of Shenyang Military Region

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2015
• First Posted: May 19, 2015
• Study Start: July 1, 2015
• Primary Completion: November 30, 2018
• Study Completion: November 1, 2022
• Last Updated: September 4, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (16)