Back to resultsChina Resolute Integrity 34/38 mm Study
Primary Purpose
Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System(34/38 mm)
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Heart Disease focused on measuring Long Lesion, In-stent Late Lumen Loss (LLL), Major Adverse Cardiac Events (MACE), MYOCARDIAL INFARCTION (MI), TARGET VESSEL REVASCULARIZATION (TVR), TARGET LESION REVASCULARIZATION (TLR), Target Vessel Failure (TVF), Target Lesion Failure (TLF), Stent Thrombosis (ST)
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, the Instructions for Use of the Resolute Integrity 34/38 mm stent
- The subject can have either a single lesion, or two lesions located in separate target vessels treated during the index procedure. Each lesion length needs to be ≤35mm with at least one lesion length >27mm and≤ 35mm and amenable for treatment with a Resolute Integrity 34/38 mm stent
Key Exclusion Criteria:
- STEMI within 24 hours
- Left main disease
- Bifurcation disease
Sites / Locations
- Beijing Friendship Hospital
- Fujian Medical University Union Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Coronary Stent
Arm Description
Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System (34/38 mm)
Outcomes
Primary Outcome Measures
Late lumen loss, in stent
Late lumen loss measured by quantitative coronary angiography (QCA)
Secondary Outcome Measures
Major Adverse Cardiac Events (MACE)
Defined as death, myocardial infarction (Q wave and non-Q wave), or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods
Death
All death
Myocardial infarction
All MI, and Target Vessel Myocardial Infarction (TVMI)
All revascularizations
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
Device Success
The attainment of <50% residual stenosis of the target lesion using only the assigned device.
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
The attainment of <50% residual stenosis of the target lesion using any percutaneous method.
The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using any percutaneous method. These measurements will be made by the independent angiographic core laboratory.
Procedure Success
The attainment of <50% residual stenosis of the target lesion and no in-hospital MACE.
The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using any percutaneous method without the occurrence of MACE during the hospital stay. These measurements will be made by the independent angiographic core laboratory.
In-stent and in-segment percent diameter stenosis (%DS)
In-stent and in-segment percent diameter stenosis (%DS)
In-stent and in-segment binary restenosis rate
In-stent and in-segment binary restenosis rate
In-stent and in-segment minimal luminal diameter (MLD)
In-stent and in-segment minimal luminal diameter (MLD)
In-segment late luminal loss
In-segment late luminal loss
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03118531
Brief Title
China Resolute Integrity 34/38 mm Study
Official Title
Evaluation of the Clinical Safety and Efficacy of the 34/38 mm Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Suitable Subjects According to the Indication for Use.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
April 17, 2017 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
April 28, 2023 (Actual)
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
5. Study Description
Brief Summary
To evaluate the clinical safety and efficacy in Chinese subjects, eligible for percutaneous transluminal coronary angioplasty (PTCA) in lesions amenable to treatment with a 34/38 mm Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System.
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
Long Lesion, In-stent Late Lumen Loss (LLL), Major Adverse Cardiac Events (MACE), MYOCARDIAL INFARCTION (MI), TARGET VESSEL REVASCULARIZATION (TVR), TARGET LESION REVASCULARIZATION (TLR), Target Vessel Failure (TVF), Target Lesion Failure (TLF), Stent Thrombosis (ST)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coronary Stent
Arm Type
Experimental
Arm Description
Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System (34/38 mm)
Intervention Type
Device
Intervention Name(s)
Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System(34/38 mm)
Intervention Description
The stenting procedure should be performed according to the Instructions for Use that is provided with each 34/38 mm Resolute Integrity stent.
Primary Outcome Measure Information:
Title
Late lumen loss, in stent
Description
Late lumen loss measured by quantitative coronary angiography (QCA)
Time Frame
9 months (m)
Secondary Outcome Measure Information:
Title
Major Adverse Cardiac Events (MACE)
Description
Defined as death, myocardial infarction (Q wave and non-Q wave), or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods
Time Frame
30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Title
Death
Description
All death
Time Frame
30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Title
Myocardial infarction
Description
All MI, and Target Vessel Myocardial Infarction (TVMI)
Time Frame
30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Title
All revascularizations
Description
Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR
Time Frame
30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Title
Target Vessel Failure (TVF)
Description
TVF
Time Frame
30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Title
Target Lesion Failure (TLF)
Description
TLF
Time Frame
30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Title
Stent Thrombosis (ST)
Description
ST
Time Frame
30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Title
Device Success
Description
The attainment of <50% residual stenosis of the target lesion using only the assigned device.
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 index procedure, an expected average of 3 days
Title
Lesion Success
Description
The attainment of <50% residual stenosis of the target lesion using any percutaneous method.
The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using any percutaneous method. These measurements will be made by the independent angiographic core laboratory.
Time Frame
At the end of index procedure, an expected average of 3 days
Title
Procedure Success
Description
The attainment of <50% residual stenosis of the target lesion and no in-hospital MACE.
The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using any percutaneous method without the occurrence of MACE during the hospital stay. These measurements will be made by the independent angiographic core laboratory.
Time Frame
Duration of hospital stay, an expected average of 5 days
Title
In-stent and in-segment percent diameter stenosis (%DS)
Description
In-stent and in-segment percent diameter stenosis (%DS)
Time Frame
9 months
Title
In-stent and in-segment binary restenosis rate
Description
In-stent and in-segment binary restenosis rate
Time Frame
9 months
Title
In-stent and in-segment minimal luminal diameter (MLD)
Description
In-stent and in-segment minimal luminal diameter (MLD)
Time Frame
9 months
Title
In-segment late luminal loss
Description
In-segment late luminal loss
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, the Instructions for Use of the Resolute Integrity 34/38 mm stent
The subject can have either a single lesion, or two lesions located in separate target vessels treated during the index procedure. Each lesion length needs to be ≤35mm with at least one lesion length >27mm and≤ 35mm and amenable for treatment with a Resolute Integrity 34/38 mm stent
Key Exclusion Criteria:
STEMI within 24 hours
Left main disease
Bifurcation disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lianglong Chen, MD
Organizational Affiliation
Fujian Medical University Union Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
12. IPD Sharing Statement
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China Resolute Integrity 34/38 mm Study
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