Back to resultsRESOLUTE Japan SVS: The Clinical Evaluation of the MDT-4107 DES in the Treatment of De Novo Lesions in Small Diameter Native Coronary Arteries (RJ-SVS)
Primary Purpose
Arterial Occlusive Diseases, Myocardial Ischemia, Cardiovascular Diseases
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
MDT-4107 Zotarolimus-Eluting Coronary Stent
Sponsored by
About this trial
This is an interventional treatment trial for Arterial Occlusive Diseases focused on measuring Medtronic, Japan, Arterial Occlusive Diseases, Myocardial Ischemia, Cardiovascular Diseases, Coronary Artery Disease, Small Vessel Stent
Eligibility Criteria
Inclusion Criteria:
- Acceptable candidate for percutaneous coronary intervention (PCI),stenting, and emergency coronary artery bypass graft surgery
- Clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study
- Informed consent
- Patient agrees to comply with specified follow-up evaluations at same investigational site
- Single target lesion or two target lesions located in separate coronary arteries
- De novo lesion(s) in native coronary artery(ies)
- Target lesion(s) ≤ 27 mm in length
- Target vessel(s) have reference vessel diameter 2.25 mm to 3.5 mm
Exclusion Criteria:
- Within 7 days of implant platelet count <100,000 cells/mm³ or >700,000 cells/mm³; White Blood Cell (wbc) count <3,000 cells/mm³; serum creatinine level >2.5 mg/dl
- Acute myocardial infarction (MI) within 72 hrs of the index procedure (Q wave myocardial infarction(QWMI)/non Q wave myocardial infarction (NQMI) or any elevation of creatinine kinease myocardial-band isoenzyme(CK-MB) > lab upper limit of normal)
- Previous PCI of target vessel(s) within 9 months prior to the procedure
- Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of target vessel(s) within 12 months post-index procedure
- History of stroke or transient ischemic attack(TIA) within prior 6 months
- Participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints
- Inability to comply with required trial antiplatelet regimen
- Previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent
- Target vessel(s) has/have other lesions w/ > 40% diameter stenosis
- Unprotected left main coronary artery disease
Sites / Locations
- Shonan Kamakura General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Drug Eluting Stent
Arm Description
Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.
Outcomes
Primary Outcome Measures
Target Lesion Failure(TLF)
Target Lesion Failure (TLF) at 9 months post-procedure defined as a composite measure of cardiac death, heart attack attributed to the target vessel (target vessel myocardial infarction), and ischemia-driven target lesion revascularization (TLR)
Secondary Outcome Measures
MACE (Major Adverse Cardiac Event)
Death, myocardial infarction (Q-wave and non-Q-wave), emergent coronary bypass, or clinically-driven repeat target lesion revascularization by percutaneous surgical methods.
Late Lumen Loss
Defined as the difference between the post-procedure immediate minimal lumen diameter (MLD) and the follow-up angiography MLD at 9 month.
Binary Angiographic Restenosis
Defined as => 50% in-stent diameter stenosis at the follow-up angiogram at 9 month. If an in-stent measurement is not available, the in-lesion diameter was used.
Minimum Luminal Diameter
The average of two orthogonal views(when possible) of narrowest point within the area of assessment-in lesion, in stent or in segment. minimal luminal diameter is visually estimated during angiography by the investigator; it is measured during quantitative coronary angiography by the Angiographic Core Laboratory.
Percent Diameter Stenosis
The value calculated as 100 x (Reference Vessel Diameter(RVD) - Minimum luminal diameter(MLD))/ RVD using the mean values from orthogonal views (when possible) by quantitative coronary angiography(QCA).
Clinical Endpoints
Success (device, lesion, procedure), major adverse cardiac events (MACE), target vessel failure (TVF), and stent thrombosis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01150500
Brief Title
RESOLUTE Japan SVS: The Clinical Evaluation of the MDT-4107 DES in the Treatment of De Novo Lesions in Small Diameter Native Coronary Arteries
Acronym
RJ-SVS
Official Title
RESOLUTE JAPAN SVS: The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent in the Treatment of De Novo Lesions in Small Diameter Native Coronary Arteries
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Vascular
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of the study is To verify the safety and efficacy of the MDT-4107 Drug-Eluting Coronary Stent in the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) that allows the use of 2.25mm diameter stents.
Detailed Description
The objective of the study is to verify the safety and efficacy of the MDT-4107 Drug-Eluting Coronary Stent in the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) that allows the use of 2.25mm diameter stents.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Occlusive Diseases, Myocardial Ischemia, Cardiovascular Diseases, Coronary Artery Disease
Keywords
Medtronic, Japan, Arterial Occlusive Diseases, Myocardial Ischemia, Cardiovascular Diseases, Coronary Artery Disease, Small Vessel Stent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug Eluting Stent
Arm Type
Experimental
Arm Description
Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.
Intervention Type
Device
Intervention Name(s)
MDT-4107 Zotarolimus-Eluting Coronary Stent
Other Intervention Name(s)
Endeavor Resolute, Zotarolimus Drug Eluting Stent, Medtronic
Primary Outcome Measure Information:
Title
Target Lesion Failure(TLF)
Description
Target Lesion Failure (TLF) at 9 months post-procedure defined as a composite measure of cardiac death, heart attack attributed to the target vessel (target vessel myocardial infarction), and ischemia-driven target lesion revascularization (TLR)
Time Frame
9 month
Secondary Outcome Measure Information:
Title
MACE (Major Adverse Cardiac Event)
Description
Death, myocardial infarction (Q-wave and non-Q-wave), emergent coronary bypass, or clinically-driven repeat target lesion revascularization by percutaneous surgical methods.
Time Frame
Baseline and 9 month
Title
Late Lumen Loss
Description
Defined as the difference between the post-procedure immediate minimal lumen diameter (MLD) and the follow-up angiography MLD at 9 month.
Time Frame
Baseline and 9 months
Title
Binary Angiographic Restenosis
Description
Defined as => 50% in-stent diameter stenosis at the follow-up angiogram at 9 month. If an in-stent measurement is not available, the in-lesion diameter was used.
Time Frame
Baseline and 9 month
Title
Minimum Luminal Diameter
Description
The average of two orthogonal views(when possible) of narrowest point within the area of assessment-in lesion, in stent or in segment. minimal luminal diameter is visually estimated during angiography by the investigator; it is measured during quantitative coronary angiography by the Angiographic Core Laboratory.
Time Frame
9 month
Title
Percent Diameter Stenosis
Description
The value calculated as 100 x (Reference Vessel Diameter(RVD) - Minimum luminal diameter(MLD))/ RVD using the mean values from orthogonal views (when possible) by quantitative coronary angiography(QCA).
Time Frame
Baseline and 9 month
Title
Clinical Endpoints
Description
Success (device, lesion, procedure), major adverse cardiac events (MACE), target vessel failure (TVF), and stent thrombosis
Time Frame
5 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acceptable candidate for percutaneous coronary intervention (PCI),stenting, and emergency coronary artery bypass graft surgery
Clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study
Informed consent
Patient agrees to comply with specified follow-up evaluations at same investigational site
Single target lesion or two target lesions located in separate coronary arteries
De novo lesion(s) in native coronary artery(ies)
Target lesion(s) ≤ 27 mm in length
Target vessel(s) have reference vessel diameter 2.25 mm to 3.5 mm
Exclusion Criteria:
Within 7 days of implant platelet count <100,000 cells/mm³ or >700,000 cells/mm³; White Blood Cell (wbc) count <3,000 cells/mm³; serum creatinine level >2.5 mg/dl
Acute myocardial infarction (MI) within 72 hrs of the index procedure (Q wave myocardial infarction(QWMI)/non Q wave myocardial infarction (NQMI) or any elevation of creatinine kinease myocardial-band isoenzyme(CK-MB) > lab upper limit of normal)
Previous PCI of target vessel(s) within 9 months prior to the procedure
Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of target vessel(s) within 12 months post-index procedure
History of stroke or transient ischemic attack(TIA) within prior 6 months
Participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints
Inability to comply with required trial antiplatelet regimen
Previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent
Target vessel(s) has/have other lesions w/ > 40% diameter stenosis
Unprotected left main coronary artery disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shigeru Saito, MD
Organizational Affiliation
Sohana Kamakura General Hosptial
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shonan Kamakura General Hospital
City
Kanagawa
ZIP/Postal Code
247-8533
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
25428602
Citation
Saito S, Maehara A, Vlachojannis GJ, Parise H, Mehran R; RESOLUTE Japan Investigators. Clinical and angiographic evaluation of the resolute zotarolimus-eluting coronary stent in Japanese patients - long-term outcome in the RESOLUTE Japan and RESOLUTE Japan small vessel study. Circ J. 2015;79(1):96-103. doi: 10.1253/circj.CJ-14-0836. Epub 2014 Nov 27.
Results Reference
derived
Links:
URL
http://clinicaltrials.medtronic.com/
Description
Medtronic Clinical Trials Link
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RESOLUTE Japan SVS: The Clinical Evaluation of the MDT-4107 DES in the Treatment of De Novo Lesions in Small Diameter Native Coronary Arteries
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