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

Primary Purpose

Coronary Heart Disease

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
MiStent
TIVOLI
Sponsored by
Micell Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring Treatment, patients, primary in situ CHD (de novo) lesions

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Third Xiangya Hospital of Central South University
  • The First Affiliated Hospital of Baotou University
  • Inner Mongolia People'S Hospital
  • The First Affiliated Hospital of Inner Mongolia Medical University
  • The Second Affiliated Hospital of Nanchang University
  • The First Affiliated Hospital of Xi'An Jiaotong University
  • Sir Run Run Shaw Hospital School of Medicine, Zhejiang University
  • The General Hospital of Shenyang Military Region
  • Fu Wai Hospital, National Center for Cardiovascular Disease
  • The First Hospital of Jilin University
  • The Second Xiangya Hospital of Central South University
  • The First Hospital of Lanzhou University
  • Shanghai Ninth People's Hospital
  • West China Hospital, Sichuan University
  • The Second Hospital of Shanxi Medical University
  • TEDA International Cardiovascular Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MiStentTM

TIVOLI

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Success rate of stent implantation (including device success, lesion success and clinical success);
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
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])
Patient-related clinical cardiovascular composite endpoints post index procedure, including all-cause death (cardiac and non-cardiac), nonfatal myocardial infarction and any revascularization
Incidence of ARC-defined stent thrombosis (definite, probable, possible stent thrombosis at early, late and very late periods)
Drug-related adverse events of dual antiplatelet therapy (DAPT) post index procedure.

Full Information

First Posted
May 15, 2015
Last Updated
September 3, 2020
Sponsor
Micell Technologies
Collaborators
Hefei Life Science Medical Instruments Co. Ltd., Giant Med-Pharma Services Inc., CCRF Consulting Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02448524
Brief Title
Clinical Trial on the Efficacy and Safety of Sirolimus-Eluting Stent (MiStent® System)
Acronym
DESSOLVE-C
Official Title
A Prospective, Single-blinded, Multi-center, Randomized, Controlled, Registered Clinical Trial on the Efficacy and Safety of Sirolimus-eluting Stent (MiStent® System) in the Treatment of Patients With Coronary Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Micell Technologies
Collaborators
Hefei Life Science Medical Instruments Co. Ltd., Giant Med-Pharma Services Inc., CCRF Consulting Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
Treatment, patients, primary in situ CHD (de novo) lesions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
428 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MiStentTM
Arm Type
Experimental
Arm Description
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).
Arm Title
TIVOLI
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
MiStent
Intervention Description
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
Intervention Name(s)
TIVOLI
Intervention Description
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).
Primary Outcome Measure Information:
Title
In-stent late lumen loss (LLL)
Description
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
Time Frame
9 months post index procedure
Secondary Outcome Measure Information:
Title
Success rate of stent implantation (including device success, lesion success and clinical success);
Time Frame
Baseline
Title
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
Time Frame
9 months
Title
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])
Time Frame
30 days, 6 months, 12 months, and 2-5 years
Title
Patient-related clinical cardiovascular composite endpoints post index procedure, including all-cause death (cardiac and non-cardiac), nonfatal myocardial infarction and any revascularization
Time Frame
30 days, 6 months, 12 months and 2-5 years
Title
Incidence of ARC-defined stent thrombosis (definite, probable, possible stent thrombosis at early, late and very late periods)
Time Frame
30 days, 6 months, 12 months and 2-5 years
Title
Drug-related adverse events of dual antiplatelet therapy (DAPT) post index procedure.
Time Frame
30 days, 6 months, 12 months and 2-5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaling Han, MD
Organizational Affiliation
The General Hospital of Shenyang Military Region
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
The First Affiliated Hospital of Baotou University
City
Baotou
State/Province
Inner Mongolia
Country
China
Facility Name
Inner Mongolia People'S Hospital
City
Hohhot
State/Province
Inner Mongolia
Country
China
Facility Name
The First Affiliated Hospital of Inner Mongolia Medical University
City
Hohhot
State/Province
Inner Mongolia
Country
China
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
The First Affiliated Hospital of Xi'An Jiaotong University
City
Xi'an
State/Province
Shaanxi
Country
China
Facility Name
Sir Run Run Shaw Hospital School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The General Hospital of Shenyang Military Region
City
Area Of Shenyang
Country
China
Facility Name
Fu Wai Hospital, National Center for Cardiovascular Disease
City
Beijing
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
Country
China
Facility Name
The First Hospital of Lanzhou University
City
Lanzhou
Country
China
Facility Name
Shanghai Ninth People's Hospital
City
Shanghai
Country
China
Facility Name
West China Hospital, Sichuan University
City
Sichuan
Country
China
Facility Name
The Second Hospital of Shanxi Medical University
City
Taiyuan
Country
China
Facility Name
TEDA International Cardiovascular Hospital
City
Tianjin
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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