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RESOLUTE China RCT (R-China RCT)

Primary Purpose

Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Taxus Liberte Paclitaxel-Eluting Coronary Stent System
Resolute Zotarolimus-Eluting Coronary Stent System
Sponsored by
Medtronic Vascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring In-stent Late Lumen Loss (LLL), TARGET VESSEL FAILURE (TVF), MYOCARDIAL INFARCTION (MI), TARGET VESSEL REVASCULARIZATION (TVR), TARGET LESION REVASCULARIZATION (TLR), TARGET LESION FAILURE (TLF), STENT THROMBOSIS, RESTENOTIC LESION, PERCUTANEOUS CORONARY INTERVENTION (PCI), REAL-WORLD, THE RANDOMIZED CONTROLLED TRIAL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient must meet all of the following criteria to be eligible for treatment in the trial:

  1. Age ≥ 18 years or minimum age as required by local regulations
  2. The patient 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 stent and Taxus Liberte stent and the Declaration of Helsinki
  3. The patient or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his/her medical information by signing a Patient Informed Consent Form
  4. Intention to electively implant at least one Resolute stent or Taxus Liberte stent
  5. The patient is willing and able to cooperate with study procedures and required follow up visits

Exclusion Criteria:

Patients will be excluded from the trial if any of the following criteria are met:

  1. Known intolerance to aspirin, clopidogrel or ticlopidin, heparin, bivalirudin, cobalt, nickel, chromium, molybdenum, 316L stainless steel, polymer coatings (e.g. Biolinx), zotarolimus, paclitaxel, rapamycin, tacrolimus, everolimus, or any other analogue or derivative, or contrast media
  2. Women with known pregnancy or who are lactating
  3. High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
  4. Currently participating in another trial that has not completed the primary endpoint or that clinically interferes with the current trial requirements
  5. Planned surgery within 6 months of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period
  6. Previous enrollment in the Resolute China RCT

Sites / Locations

  • An Zhen Hospital
  • Beijing Fu Wai Hospital
  • The First Affiliated Hospital, Sun Yat-sen University
  • First Affiliated Hospital of Medical College of XI'AN Jiaotong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Taxus Liberte Paclitaxel-Eluting Coronary Stent System

Medtronic Resolute (Zotarolimus-eluting stent)

Arm Description

Subjects will be randomized to be treated with Taxus Liberte Paclitaxel-Eluting Coronary Stent System by an interactive voice response system (IVRS).

Subjects will be randomized to be treated with Medtronic Resolute (Zotarolimus-eluting stent) by an interactive voice response system (IVRS).

Outcomes

Primary Outcome Measures

in-stent late lumen loss (LLL)
in-stent late lumen loss (LLL), defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiography MLD.

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. If the core laboratory is unable to assess the % residual stenosis, the Investigator's assessment as recorded in the CRF will be used for the statistical analysis.
Death
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.
Myocardial infarction
All myocardial infarction data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions.
MACE composite endpoint
Death, myocardial infarction (MI) (Q wave and non-Q wave), emergent coronary bypass surgery (CABG), or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods.
Composite endpoint of (all cause) mortality, Myocardial Infarction (Q-wave and non Q-wave) or (any) revascularization
Mortality, Myocardial Infarction (Q-wave and non Q wave) or (any) revascularization.
All revascularizations
Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR.
Target lesion failure (TLF)
A composite endpoint of cardiac death, target vessel myocardial infarction (Q wave and non Q wave) or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods.
Target vessel failure (TVF)
A composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization(TVR.
Stent thrombosis
As determined by Medtronic historic and ARC definitions.
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 any percutaneous method. These measurements will be made by the independent angiographic core laboratory. If the core laboratory is unable to assess the % residual stenosis, the Investigator's assessment as recorded in the CRF will be used for the statistical analysis.
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 any percutaneous method without the occurrence of MACE during the hospital stay. These measurements will be made by the independent angiographic core laboratory. If the core laboratory is unable to assess the % residual stenosis, the Investigator's assessment as recorded in the CRF will be used for the statistical analysis.

Full Information

First Posted
April 11, 2011
Last Updated
October 16, 2017
Sponsor
Medtronic Vascular
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1. Study Identification

Unique Protocol Identification Number
NCT01334268
Brief Title
RESOLUTE China RCT
Acronym
R-China RCT
Official Title
A Randomized Controlled Trial of the Resolute Zotarolimus-Eluting Stent Versus the Taxus Liberte Paclitaxel-Eluting Stent for Percutaneous Coronary Intervention in a Real-World All-comer Patient Population in China
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2011 (Actual)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
June 30, 2017 (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 primary objective of this study is to evaluate the in-stent late lumen loss (LLL) at 9 months, defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiography MLD, of the Resolute Zotarolimus-Eluting Coronary Stent System compared to Taxus Liberte Paclitaxel-Eluting Coronary Stent System in a real-world all-comer patient population requiring stent implantation.
Detailed Description
This study is a prospective, multicenter, randomized, two-arm, open-label study, designed to assess the non-inferiority of Resolute stent compared to Taxus Liberte stent in in-stent late lumen loss. The primary objective of this study is to evaluate the in-stent late lumen loss (LLL) at 9 months, defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiography MLD, of the Resolute Zotarolimus-Eluting Coronary Stent System compared to Taxus Liberte Paclitaxel-Eluting Coronary Stent System in a real-world all-comer patient population requiring stent implantation. This trial will be conducted at approximately 20 sites and will enroll up to 400 subjects, randomized to the Resolute stent and Taxus Liberte stent in a 1:1 ratio. Subjects will be randomized using an interactive voice response system (IVRS). Due to the design characteristics of the devices, the study investigators and operators can not be blinded. However, the clinical event adjudication committee, consisting of cardiologists who are not participating in the study, will be blinded for the treatment arm of the subjects to avoid a potential bias in the adjudication process of events.

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
In-stent Late Lumen Loss (LLL), TARGET VESSEL FAILURE (TVF), MYOCARDIAL INFARCTION (MI), TARGET VESSEL REVASCULARIZATION (TVR), TARGET LESION REVASCULARIZATION (TLR), TARGET LESION FAILURE (TLF), STENT THROMBOSIS, RESTENOTIC LESION, PERCUTANEOUS CORONARY INTERVENTION (PCI), REAL-WORLD, THE RANDOMIZED CONTROLLED TRIAL

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Taxus Liberte Paclitaxel-Eluting Coronary Stent System
Arm Type
Active Comparator
Arm Description
Subjects will be randomized to be treated with Taxus Liberte Paclitaxel-Eluting Coronary Stent System by an interactive voice response system (IVRS).
Arm Title
Medtronic Resolute (Zotarolimus-eluting stent)
Arm Type
Experimental
Arm Description
Subjects will be randomized to be treated with Medtronic Resolute (Zotarolimus-eluting stent) by an interactive voice response system (IVRS).
Intervention Type
Device
Intervention Name(s)
Taxus Liberte Paclitaxel-Eluting Coronary Stent System
Other Intervention Name(s)
Taxus
Intervention Description
Taxus Liberte Paclitaxel-Eluting Coronary Stent System Implantation
Intervention Type
Device
Intervention Name(s)
Resolute Zotarolimus-Eluting Coronary Stent System
Other Intervention Name(s)
Resolute
Intervention Description
Resolute Zotarolimus-Eluting Coronary Stent System Implantation
Primary Outcome Measure Information:
Title
in-stent late lumen loss (LLL)
Description
in-stent late lumen loss (LLL), defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiography MLD.
Time Frame
9 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. If the core laboratory is unable to assess the % residual stenosis, the Investigator's assessment as recorded in the CRF will be used for the statistical analysis.
Time Frame
at the end of the index procedure or during hospital stay
Title
Death
Description
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.
Time Frame
30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Title
Myocardial infarction
Description
All myocardial infarction data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions.
Time Frame
30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Title
MACE composite endpoint
Description
Death, myocardial infarction (MI) (Q wave and non-Q wave), emergent coronary bypass surgery (CABG), or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods.
Time Frame
30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Title
Composite endpoint of (all cause) mortality, Myocardial Infarction (Q-wave and non Q-wave) or (any) revascularization
Description
Mortality, Myocardial Infarction (Q-wave and non Q wave) or (any) revascularization.
Time Frame
30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Title
All revascularizations
Description
Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR.
Time Frame
30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Title
Target lesion failure (TLF)
Description
A composite endpoint of cardiac death, target vessel myocardial infarction (Q wave and non Q wave) or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods.
Time Frame
30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Title
Target vessel failure (TVF)
Description
A composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization(TVR.
Time Frame
30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Title
Stent thrombosis
Description
As determined by Medtronic historic and ARC definitions.
Time Frame
30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
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 any percutaneous method. These measurements will be made by the independent angiographic core laboratory. If the core laboratory is unable to assess the % residual stenosis, the Investigator's assessment as recorded in the CRF will be used for the statistical analysis.
Time Frame
At the end of the index procedure or during hospital stay
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 any percutaneous method without the occurrence of MACE during the hospital stay. These measurements will be made by the independent angiographic core laboratory. If the core laboratory is unable to assess the % residual stenosis, the Investigator's assessment as recorded in the CRF will be used for the statistical analysis.
Time Frame
At the end of the index procedure or during hospital stay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient must meet all of the following criteria to be eligible for treatment in the trial: Age ≥ 18 years or minimum age as required by local regulations The patient 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 stent and Taxus Liberte stent and the Declaration of Helsinki The patient or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his/her medical information by signing a Patient Informed Consent Form Intention to electively implant at least one Resolute stent or Taxus Liberte stent The patient is willing and able to cooperate with study procedures and required follow up visits Exclusion Criteria: Patients will be excluded from the trial if any of the following criteria are met: Known intolerance to aspirin, clopidogrel or ticlopidin, heparin, bivalirudin, cobalt, nickel, chromium, molybdenum, 316L stainless steel, polymer coatings (e.g. Biolinx), zotarolimus, paclitaxel, rapamycin, tacrolimus, everolimus, or any other analogue or derivative, or contrast media Women with known pregnancy or who are lactating High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) Currently participating in another trial that has not completed the primary endpoint or that clinically interferes with the current trial requirements Planned surgery within 6 months of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period Previous enrollment in the Resolute China RCT
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuzheng Lv
Organizational Affiliation
An Zhen Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yundai Chen
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhimin Du
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bo Xu
Organizational Affiliation
Beijing Fu Wai Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yuejin Yang, MD
Organizational Affiliation
Fu Wai Hospital, Beijing, China
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zuyi Yuan
Organizational Affiliation
First Affiliated Hospital of Medical College of ZI'AN Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
An Zhen Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Beijing Fu Wai Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
First Affiliated Hospital of Medical College of XI'AN Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
23523240
Citation
Xu B, Yang Y, Yuan Z, Du Z, Wong SC, Genereux P, Lu S; RESOLUTE China RCT Investigators. Zotarolimus- and paclitaxel-eluting stents in an all-comer population in China: the RESOLUTE China randomized controlled trial. JACC Cardiovasc Interv. 2013 Jul;6(7):664-70. doi: 10.1016/j.jcin.2013.03.001. Epub 2013 Mar 21.
Results Reference
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