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Coronary Heart DiseasePhase 3DESSOLVE-CNCT02448524

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

A Phase 3 study testing MiStent and TIVOLI in people with Coronary Heart Disease, run by Micell Technologies at 16 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Coronary Heart Disease
What is being tested?
MiStent and TIVOLI
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
428 participants
Where
16 sitesChina
Study dates
Jul 2015to Nov 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 13Show fewer
  • 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.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

China16 sites

  • The General Hospital of Shenyang Military Region

    Area of Shenyang

  • The First Affiliated Hospital of Baotou University

    Baotou, Inner Mongolia

  • Fu Wai Hospital, National Center for Cardiovascular Disease

    Beijing

  • The First Hospital of Jilin University

    Changchun

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan

  • The Second Xiangya Hospital of Central South University

    Changsha

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

    Hangzhou, Zhejiang

  • Inner Mongolia People'S Hospital

    Hohhot, Inner Mongolia

  • The First Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia

  • The First Hospital of Lanzhou University

    Lanzhou

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • Shanghai Ninth People's Hospital

    Shanghai

  • West China Hospital, Sichuan University

    Sichuan

  • The Second Hospital of Shanxi Medical University

    Taiyuan

  • TEDA International Cardiovascular Hospital

    Tianjin

  • The First Affiliated Hospital of Xi'An Jiaotong University

    Xi'an, Shaanxi

Other trials in China

About this study

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

  • 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.
Read the 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.
Being tested
MiStent, TIVOLI
Keywords
Treatment, patients, primary in situ CHD (de novo) lesions
Medical subject headings
Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MiStentDevice

    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).

  • TIVOLIDevice

    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).

Study groups in NCT02448524
Study groupRoleWhat they receive
MiStentTMExperimentalMiStentTM 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).
Receives: Device: MiStent
TIVOLIActive comparatorTIVOLI 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.
Receives: Device: TIVOLI

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 9 months post index procedure

Secondary outcomes (6)

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

    Measured: Baseline

  2. 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

    Measured: 9 months

  3. 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])

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

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

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

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

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

  6. Drug-related adverse events of dual antiplatelet therapy (DAPT) post index procedure.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2015 (estimated)
  2. Study startJul 2015
  3. Primary completion30 Nov 2018
  4. Study completionNov 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
428 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02448524
Sponsor's protocol ID
MiStent01
Acronym
DESSOLVE-C
Status last verified
Sep 2020
First submitted
15 May 2015
Last updated
4 Sep 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MiStent and TIVOLI in people with Coronary Heart Disease, run by Micell Technologies at 16 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-stent late lumen loss (LLL) (time frame: 9 months post index procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02448524.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.

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