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Trial of MiStent Compared to Xience in Japan (DESSOLVEJ)

Primary Purpose

Coronary (Artery); Disease

Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
MiStent (MT005) Coronary Artery Stent
Xience Coronary Artery Stent
Sponsored by
Micell Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary (Artery); Disease focused on measuring MiStent

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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;

Sites / Locations

  • Iwaki Municipal Iwaki Kyoritsu Hospital
  • Kansai Rosai Hospital
  • Tenyokai Central Hospital
  • Kanto Rosai Hospital
  • Sinkoga Hospital
  • Omihachiman Community Medical Center
  • Toho Univ.Ohashi Medical Center
  • Cardiovascular Institute Hospital
  • Saiseikai Yokohama Tobu Hospital
  • Shonan Kamakura General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MiStent (MT005) Coronary Artery Stent

Xience Coronary Artery Stent

Arm Description

A balloon expandable crystalline sirolimus eluting stent with an absorbable polymer coating will be implanted.

Balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating will be implanted

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
November 16, 2016
Last Updated
September 3, 2020
Sponsor
Micell Technologies
Collaborators
Cardialysis BV, ClinLogix. LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02972671
Brief Title
Trial of MiStent Compared to Xience in Japan
Acronym
DESSOLVEJ
Official Title
Multicenter Randomized Study of the MiStent Sirolimus Eluting Absorbable Polymer Stent System (MT005) for Revascularization of Coronary Arteries
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 28, 2016 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Micell Technologies
Collaborators
Cardialysis BV, ClinLogix. LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary (Artery); Disease
Keywords
MiStent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MiStent (MT005) Coronary Artery Stent
Arm Type
Experimental
Arm Description
A balloon expandable crystalline sirolimus eluting stent with an absorbable polymer coating will be implanted.
Arm Title
Xience Coronary Artery Stent
Arm Type
Active Comparator
Arm Description
Balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating will be implanted
Intervention Type
Device
Intervention Name(s)
MiStent (MT005) Coronary Artery Stent
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Xience Coronary Artery Stent
Intervention Description
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
Primary Outcome Measure Information:
Title
Target Lesion Failure (TLF)-Composite of Target Lesion Revascularization (TLR), Target Vessel MI (TV MI), and Cardiac Death
Description
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.
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Target Lesion Revascularization (TLR)
Description
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.
Time Frame
12 Months
Title
Target Vessel Myocardial Infarction (TV-MI)
Description
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.
Time Frame
12 Months
Title
Cardiac Death
Description
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.
Time Frame
12 Months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shigeru Saito, MD
Organizational Affiliation
Shonan Kamakura General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iwaki Municipal Iwaki Kyoritsu Hospital
City
Iwaki-shi
State/Province
Fukushima
Country
Japan
Facility Name
Kansai Rosai Hospital
City
Amagasaki-shi
State/Province
Hyogo
Country
Japan
Facility Name
Tenyokai Central Hospital
City
Kagoshima-shi
State/Province
Kagoshima
Country
Japan
Facility Name
Kanto Rosai Hospital
City
Kawasaki-shi
State/Province
Kanagawa
Country
Japan
Facility Name
Sinkoga Hospital
City
Kurume-shi
State/Province
Kurume-shi, Fukuoka
Country
Japan
Facility Name
Omihachiman Community Medical Center
City
Omihachiman-shi
State/Province
Shiga
ZIP/Postal Code
523-0082
Country
Japan
Facility Name
Toho Univ.Ohashi Medical Center
City
Meguro-ku
State/Province
Tokyo
Country
Japan
Facility Name
Cardiovascular Institute Hospital
City
Minato-ku
State/Province
Tokyo
Country
Japan
Facility Name
Saiseikai Yokohama Tobu Hospital
City
Kanagawa
State/Province
Yokohama
Country
Japan
Facility Name
Shonan Kamakura General Hospital
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

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Trial of MiStent Compared to Xience in Japan

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