Coronary (Artery); DiseaseDESSOLVEJNCT02972671
Trial of MiStent Compared to Xience in Japan
A study testing MiStent (MT005) Coronary Artery Stent and Xience Coronary Artery Stent in people with Coronary (Artery); Disease, run by Micell Technologies at 10 sites in Japan.
Trial summary
To compare the MT005 (MiStent) with the XIENCE with respect to target lesion failure (TLF) at 12 months in a non-inferiority trial in a "real world" patient population and to confirm that the domestic extrapolation of the DESSOLVE III study results is valid. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Coronary (Artery); Disease
- What is being tested?
- MiStent (MT005) Coronary Artery Stent and Xience Coronary Artery Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 10 sitesJapan
- Study dates
- 28 Nov 2016to 30 Apr 2022
- Phase
- Interventional
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ≥20 years;
- Patients who are eligible for percutaneous coronary intervention (PCI);
- The vessel should have a reference vessel diameter ranging from 2.5 mm to 3.75 mm. All lesions of the patient must comply with the angiographic inclusion criteria and no more than 4 stents per patient are to be implanted.
- The patient is judged to be capable of providing voluntary informed consent and has been fully informed of the nature of the study, is willing to comply with all study requirements and will provide written informed consent as approved by the Ethics Committee of the respective clinical site.
Who cannot join
- Known pregnancy or breastfeeding at time of randomization or planned pregnancy for 12 months after the index treatment. Women of childbearing potential must have a negative pregnancy test within 7 days of randomization;
- Known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium, or to medications such as aspirin, heparin, bivalirudin, and all of the following three medications: clopidogrel bisulfate, ticlopidine, prasugrel;
- Concurrent medical condition with a life expectancy of less than 12 months;
- The patient is unwilling/not able to return for outpatient clinic at 1, 6 and 12 months follow-up;
- Currently participating in another trial and not yet at its primary endpoint;
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Japan10 sites
Kansai Rosai Hospital
Amagasaki-shi, Hyōgo
Iwaki Municipal Iwaki Kyoritsu Hospital
Iwaki, Fukushima
Tenyokai Central Hospital
Kagoshima, Kagoshima-ken
Saiseikai Yokohama Tobu Hospital
Kanagawa, Yokohama
Kanto Rosai Hospital
Kawasaki-shi, Kanagawa
Sinkoga Hospital
Kurume-shi, Kurume-shi, Fukuoka
Toho Univ.Ohashi Medical Center
Meguro-ku, Tokyo
Cardiovascular Institute Hospital
Minato-ku, Tokyo
Omihachiman Community Medical Center
Ōmihachiman, Shiga, 523-0082
Shonan Kamakura General Hospital
Tokyo
About this study
Official title: Multicenter Randomized Study of the MiStent Sirolimus Eluting Absorbable Polymer Stent System (MT005) for Revascularization of Coronary Arteries
To compare the MT005 (MiStent) with the XIENCE with respect to target lesion failure (TLF) at 12 months in a non-inferiority trial in a "real world" patient population and to confirm that the domestic extrapolation of the DESSOLVE III study results is valid.
Read the detailed description
This is a prospective, randomized, 1:1 balanced, controlled, double-blind, multi-center study comparing clinical outcomes at 12 months between MT005 (MiStent) and XIENCE in an all-comers population, including patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions.
- Conditions
- Coronary (Artery); Disease
- Being tested
- MiStent (MT005) Coronary Artery Stent, Xience Coronary Artery Stent
- Keywords
- MiStent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiStent (MT005) Coronary Artery StentDevice
Implantation of a coronary artery stent in an all-comers population, including patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions
Xience Coronary Artery StentDevice
Implantation of a coronary artery stent in an all-comers population, including patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions
| Study group | Role | What they receive |
|---|---|---|
| MiStent (MT005) Coronary Artery Stent | Experimental | A balloon expandable crystalline sirolimus eluting stent with an absorbable polymer coating will be implanted. Receives: Device: MiStent (MT005) Coronary Artery Stent |
| Xience Coronary Artery Stent | Active comparator | Balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating will be implanted Receives: Device: Xience Coronary Artery Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Failure (TLF)-Composite of Target Lesion Revascularization (TLR), Target Vessel MI (TV MI), and Cardiac Death
The proportion of patients in each arm that experience TLF will be summarized and reported. No formal comparison of the two arms will be conducted. Portions will be reported at 12 months post procedure.
Measured: 12 Months
Secondary outcomes (3)
Target Lesion Revascularization (TLR)
The proportion of patients in each arm that experience TLR will be summarized and reported. No formal comparison of the two arms will be conducted. Portions will be reported at 12 months post procedure.
Measured: 12 Months
Target Vessel Myocardial Infarction (TV-MI)
The proportion of patients in each arm that experience TV-MI will be summarized and reported. No formal comparison of the two arms will be conducted. Portions will be reported at 12 months post procedure.
Measured: 12 Months
Cardiac Death
The proportion of patients in each arm that experience Cardiac Death will be summarized and reported. No formal comparison of the two arms will be conducted. Portions will be reported at 12 months post procedure.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study start28 Nov 2016
- Primary completion30 Apr 2018
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary (Artery); DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Micell Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cardialysis BV, ClinLogix. LLC
- Responsible party
- Sponsor
- Investigators
- Shigeru Saito, MD, Principal investigator, Shonan Kamakura General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972671
- Sponsor's protocol ID
- MIS-JPN-2016-05
- Acronym
- DESSOLVEJ
- Status last verified
- Sep 2020
- First submitted
- 16 Nov 2016
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Study of the MiStent Sirolimus Eluting Absorbable Polymer Stent System (MT005) for Revascularization of Coronary Arteries
- ClinicalTrials.gov ID
- NCT02972671
- Acronym / sponsor ID
- DESSOLVEJ / MIS-JPN-2016-05
- Conditions
- Coronary (Artery); Disease
- Keywords
- MiStent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Micell TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- Cardialysis BV, ClinLogix. LLC
- Study start
- 28 Nov 2016 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 23 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the MT005 (MiStent) with the XIENCE with respect to target lesion failure (TLF) at 12 months in a non-inferiority trial in a "real world" patient population and to confirm that the domestic extrapolation of the DESSOLVE III study results is valid.
Detailed description
This is a prospective, randomized, 1:1 balanced, controlled, double-blind, multi-center study comparing clinical outcomes at 12 months between MT005 (MiStent) and XIENCE in an all-comers population, including patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MiStent (MT005) Coronary Artery Stent | Experimental | Device: MiStent (MT005) Coronary Artery StentA balloon expandable crystalline sirolimus eluting stent with an absorbable polymer coating will be implanted. |
| Xience Coronary Artery Stent | Active comparator | Device: Xience Coronary Artery StentBalloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating will be implanted |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients ≥20 years;
- Patients who are eligible for percutaneous coronary intervention (PCI);
- The vessel should have a reference vessel diameter ranging from 2.5 mm to 3.75 mm. All lesions of the patient must comply with the angiographic inclusion criteria and no more than 4 stents per patient are to be implanted.
- The patient is judged to be capable of providing voluntary informed consent and has been fully informed of the nature of the study, is willing to comply with all study requirements and will provide written informed consent as approved by the Ethics Committee of the respective clinical site.
Key exclusion criteria (5 listed)
- Known pregnancy or breastfeeding at time of randomization or planned pregnancy for 12 months after the index treatment. Women of childbearing potential must have a negative pregnancy test within 7 days of randomization;
- Known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium, or to medications such as aspirin, heparin, bivalirudin, and all of the following three medications: clopidogrel bisulfate, ticlopidine, prasugrel;
- Concurrent medical condition with a life expectancy of less than 12 months;
- The patient is unwilling/not able to return for outpatient clinic at 1, 6 and 12 months follow-up;
- Currently participating in another trial and not yet at its primary endpoint;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiStent (MT005) Coronary Artery StentImplantation of a coronary artery stent in an all-comers population, including patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions | Device | MiStent (MT005) Coronary Artery Stent |
| Xience Coronary Artery StentImplantation of a coronary artery stent in an all-comers population, including patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions | Device | Xience Coronary Artery Stent |
Primary outcome
Target Lesion Failure (TLF)-Composite of Target Lesion Revascularization (TLR), Target Vessel MI (TV MI), and Cardiac Death
Time frame: 12 Months
The proportion of patients in each arm that experience TLF will be summarized and reported. No formal comparison of the two arms will be conducted. Portions will be reported at 12 months post procedure.
3 secondary outcomes
Target Lesion Revascularization (TLR)
Time frame: 12 Months
Target Vessel Myocardial Infarction (TV-MI)
Time frame: 12 Months
Cardiac Death
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Coronary (Artery); Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shigeru Saito, MD principal investigator
Shonan Kamakura General Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MiStent (MT005) Coronary Artery Stent and Xience Coronary Artery Stent in people with Coronary (Artery); Disease, run by Micell Technologies at 10 sites in Japan.
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 4 inclusion and 5 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 10 sites in Japan. 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.
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?
Target Lesion Failure (TLF)-Composite of Target Lesion Revascularization (TLR), Target Vessel MI (TV MI), and Cardiac Death (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.