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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02972671 |
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Date of registration:
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16/11/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Trial of MiStent Compared to Xience in Japan
DESSOLVEJ |
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Scientific title:
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Multicenter Randomized Study of the MiStent Sirolimus Eluting Absorbable Polymer Stent System (MT005) for Revascularization of Coronary Arteries |
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Date of first enrolment:
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November 28, 2016 |
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Target sample size:
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120 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02972671 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Japan
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Contacts
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Name:
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Shigeru Saito, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Shonan Kamakura General Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Coronary (Artery); Disease
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Intervention(s)
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Device: Xience Coronary Artery Stent
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Device: MiStent (MT005) Coronary Artery Stent
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Primary Outcome(s)
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Target Lesion Failure (TLF)-Composite of Target Lesion Revascularization (TLR), Target Vessel MI (TV MI), and Cardiac Death
[Time Frame: 12 Months]
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Secondary Outcome(s)
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Target Lesion Revascularization (TLR)
[Time Frame: 12 Months]
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Cardiac Death
[Time Frame: 12 Months]
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Target Vessel Myocardial Infarction (TV-MI)
[Time Frame: 12 Months]
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Secondary ID(s)
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MIS-JPN-2016-05
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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