Back to resultsRESOLUTE ONYX China Single Arm Study
Primary Purpose
Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Heart Disease focused on measuring Major Adverse Cardiac Events (MACE), Myocardial Infarction (MI), Late Lumen Loss (LLL), Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), Target Vessel Failure (TVF), Target Lesion Failure (TLF), Stent Thrombosis (ST), PERCUTANEOUS CORONARY INTERVENTION (PCI)
Eligibility Criteria
Key Inclusion Criteria:
- The subject is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, and the IB of Resolute Onyx stent.
- The subject requires treatment of up to 3 target lesions in up to 2 separate target vessels [2 target lesions in 1 vessel (including its side branches) and 1 target lesion in a separate vessel (including its side branches)] amenable to treatment with stents with diameter from 2.25 mm to 5.0 mm
Key Exclusion Criteria:
- Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, P2Y12 inhibitors, mTOR inhibiting drugs such as zotarolimus, Biolimus A9 (or its derivatives), cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
- PCI of the target vessel within 9 months prior to the procedure
- Active bleeding
- Subjects with a life expectancy of less than 12 months
- Participation in another clinical study
- Pregnant, or lactating women
Sites / Locations
- Affiliated Hospital of Jiangsu University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Arm Description
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Outcomes
Primary Outcome Measures
Target Lesion Failure (TLF)
TLF
Secondary Outcome Measures
Device Success
Definition 1: The attainment of <50% residual stenosis of the target lesion using only the assigned device.
Definition 2: The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using the assigned device only. These measurements will be made by the independent angiographic core laboratory.
Lesion Success
Definition 1: The attainment of <50% residual stenosis of the target lesion using any percutaneous method.
Definition 2: The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using the assigned device only. These measurements will be made by the independent angiographic core laboratory.
Procedure Success
Definition 1: The attainment of <50% residual stenosis of the target lesion and no in-hospital MACE.
Definition 2: The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using the assigned device only. These measurements will be made by the independent angiographic core laboratory.
Major Adverse Cardiac Events (MACE)
Defined as composite of death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods
Death (Cardiac and Non-cardiac)
All deaths
Myocardial infarction (all MI, and Target Vessel Myocardial Infarction (TVMI))
All myocardial infarction data will be reported per Medtronic historical protocol definitions.
All revascularizations
Combined endpoints including Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR
Target Vessel Failure (TVF)
TVF
Target Lesion Failure (TLF)
TLF
Stent Thrombosis (ST)
ST
In-stent late luminal loss
Only for subjects implanted with certain stent sizes: Angiographic measures: In-stent and In-segment late luminal loss
In-segment late luminal loss
Only for subjects implanted with certain stent sizes: Angiographic measures: In-stent and In-segment late luminal loss
In-stent and in-segment percent diameter stenosis (%DS)
Only for subjects implanted with certain stent sizes: Angiographic measures: In-stent and in-segment percent diameter stenosis (%DS)
In-stent and in-segment binary restenosis rate
Only for subjects implanted with certain stent sizes: Angiographic measures: In-stent and in-segment binary restenosis rate
In-stent and in-segment minimal luminal diameter (MLD)
Only for subjects implanted with certain stent sizes: Angiographic measures:In-stent and in-segment minimal luminal diameter (MLD)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03471845
Brief Title
RESOLUTE ONYX China Single Arm Study
Official Title
A Single Arm Clinical Evaluation of Safety and Efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Subjects Eligible for Percutaneous Transluminal Coronary Angioplasty (PTCA) in China
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 30, 2018 (Actual)
Primary Completion Date
February 24, 2021 (Actual)
Study Completion Date
October 2, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Vascular
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
It is a single arm clinical evaluation of safety and efficacy of the Medtronic Resolute Onyx™ zotarolimus-eluting coronary stent system in subjects who are eligible for percutaneous transluminal coronary angioplasty (PTCA) in de novo lesions amenable to treatment with Resolute Onyx™ Stent System in China.
Detailed Description
This study is a pre-Market, prospective, multi-center, single arm trial. Subjects will be enrolled and followed through 5 Years (screen, implant procedure(including post-procedure assessment),30-Day, 6 Months, 9 Months-subjects implanted with fringe size, and annual assessments from 1-5 years).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis, Coronary Artery Disease
Keywords
Major Adverse Cardiac Events (MACE), Myocardial Infarction (MI), Late Lumen Loss (LLL), Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), Target Vessel Failure (TVF), Target Lesion Failure (TLF), Stent Thrombosis (ST), PERCUTANEOUS CORONARY INTERVENTION (PCI)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
591 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Arm Type
Experimental
Arm Description
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Intervention Type
Device
Intervention Name(s)
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Intervention Description
Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements
Primary Outcome Measure Information:
Title
Target Lesion Failure (TLF)
Description
TLF
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Device Success
Description
Definition 1: The attainment of <50% residual stenosis of the target lesion using only the assigned device.
Definition 2: The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using the assigned device only. These measurements will be made by the independent angiographic core laboratory.
Time Frame
at the end of the index procedure or during hospital stay:estimated 7 days
Title
Lesion Success
Description
Definition 1: The attainment of <50% residual stenosis of the target lesion using any percutaneous method.
Definition 2: The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using the assigned device only. These measurements will be made by the independent angiographic core laboratory.
Time Frame
at the end of the index procedure or during hospital stay: estimated 7 days
Title
Procedure Success
Description
Definition 1: The attainment of <50% residual stenosis of the target lesion and no in-hospital MACE.
Definition 2: The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using the assigned device only. These measurements will be made by the independent angiographic core laboratory.
Time Frame
at the end of the index procedure or during hospital stay: estimated 7 days
Title
Major Adverse Cardiac Events (MACE)
Description
Defined as composite of death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods
Time Frame
30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
Title
Death (Cardiac and Non-cardiac)
Description
All deaths
Time Frame
30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
Title
Myocardial infarction (all MI, and Target Vessel Myocardial Infarction (TVMI))
Description
All myocardial infarction data will be reported per Medtronic historical protocol definitions.
Time Frame
30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
Title
All revascularizations
Description
Combined endpoints including Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR
Time Frame
30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
Title
Target Vessel Failure (TVF)
Description
TVF
Time Frame
30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
Title
Target Lesion Failure (TLF)
Description
TLF
Time Frame
30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
Title
Stent Thrombosis (ST)
Description
ST
Time Frame
30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
Title
In-stent late luminal loss
Description
Only for subjects implanted with certain stent sizes: Angiographic measures: In-stent and In-segment late luminal loss
Time Frame
9 months
Title
In-segment late luminal loss
Description
Only for subjects implanted with certain stent sizes: Angiographic measures: In-stent and In-segment late luminal loss
Time Frame
9 months
Title
In-stent and in-segment percent diameter stenosis (%DS)
Description
Only for subjects implanted with certain stent sizes: Angiographic measures: In-stent and in-segment percent diameter stenosis (%DS)
Time Frame
9 months
Title
In-stent and in-segment binary restenosis rate
Description
Only for subjects implanted with certain stent sizes: Angiographic measures: In-stent and in-segment binary restenosis rate
Time Frame
9 months
Title
In-stent and in-segment minimal luminal diameter (MLD)
Description
Only for subjects implanted with certain stent sizes: Angiographic measures:In-stent and in-segment minimal luminal diameter (MLD)
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
The subject is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, and the IB of Resolute Onyx stent.
The subject requires treatment of up to 3 target lesions in up to 2 separate target vessels [2 target lesions in 1 vessel (including its side branches) and 1 target lesion in a separate vessel (including its side branches)] amenable to treatment with stents with diameter from 2.25 mm to 5.0 mm
Key Exclusion Criteria:
Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, P2Y12 inhibitors, mTOR inhibiting drugs such as zotarolimus, Biolimus A9 (or its derivatives), cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
PCI of the target vessel within 9 months prior to the procedure
Active bleeding
Subjects with a life expectancy of less than 12 months
Participation in another clinical study
Pregnant, or lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben He, MD
Organizational Affiliation
Shanghai Chest Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Hospital of Jiangsu University
City
Zhenjiang
State/Province
Jiangsu
Country
China
12. IPD Sharing Statement
Learn more about this trial
RESOLUTE ONYX China Single Arm Study
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