Ischemic Heart DiseaseR-China RCTNCT01334268
RESOLUTE China RCT
A study testing Taxus Liberte Paclitaxel-Eluting Coronary Stent System and Resolute Zotarolimus-Eluting Coronary Stent System in people with Ischemic Heart Disease and Stenotic Coronary Lesion, run by Medtronic Vascular at 4 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases
- What is being tested?
- Taxus Liberte Paclitaxel-Eluting Coronary Stent System and Resolute Zotarolimus-Eluting Coronary Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 4 sitesChina
- Study dates
- Sep 2011to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
China4 sites
An Zhen Hospital
Beijing, Beijing Municipality, 100029
Beijing Fu Wai Hospital
Beijing, Beijing Municipality, 100037
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
First Affiliated Hospital of Medical College of XI'AN Jiaotong University
Xi'an, Shaanxi, 710061
About this study
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
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.
Read the 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.
- Conditions
- Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis, Coronary Artery Disease
- Being tested
- Taxus Liberte Paclitaxel-Eluting Coronary Stent System, Resolute Zotarolimus-Eluting Coronary Stent System
- 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
- Medical subject headings
- Myocardial Ischemia, Cardiovascular Diseases, Arteriosclerosis, Coronary Artery Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taxus Liberte Paclitaxel-Eluting Coronary Stent SystemDevice
Also called Taxus
Taxus Liberte Paclitaxel-Eluting Coronary Stent System Implantation
Resolute Zotarolimus-Eluting Coronary Stent SystemDevice
Also called Resolute
Resolute Zotarolimus-Eluting Coronary Stent System Implantation
| Study group | Role | What they receive |
|---|---|---|
| Taxus Liberte Paclitaxel-Eluting Coronary Stent System | Active comparator | Subjects will be randomized to be treated with Taxus Liberte Paclitaxel-Eluting Coronary Stent System by an interactive voice response system (IVRS). Receives: Device: Taxus Liberte Paclitaxel-Eluting Coronary Stent System |
| Medtronic Resolute (Zotarolimus-eluting stent) | Experimental | Subjects will be randomized to be treated with Medtronic Resolute (Zotarolimus-eluting stent) by an interactive voice response system (IVRS). Receives: Device: Resolute Zotarolimus-Eluting Coronary Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Secondary outcomes (11)
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.
Measured: at the end of the index procedure or during hospital stay
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.
Measured: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Myocardial infarction
All myocardial infarction data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions.
Measured: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
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.
Measured: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
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.
Measured: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
All revascularizations
Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR.
Measured: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
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.
Measured: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Target vessel failure (TVF)
A composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization(TVR.
Measured: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Stent thrombosis
As determined by Medtronic historic and ARC definitions.
Measured: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
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.
Measured: At the end of the index procedure or during hospital stay
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.
Measured: At the end of the index procedure or during hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2012
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shuzheng Lv, Principal investigator, An Zhen HospitalYundai Chen, Principal investigator, Chinese PLA General HospitalZhimin Du, Principal investigator, First Affiliated Hospital, Sun Yat-Sen UniversityBo Xu, Principal investigator, Beijing Fu Wai HospitalYuejin Yang, MD, Principal investigator, Fu Wai Hospital, Beijing, ChinaZuyi Yuan, Principal investigator, First Affiliated Hospital of Medical College of ZI'AN Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334268
- Sponsor's protocol ID
- IP 10009066DOC
- Acronym
- R-China RCT
- Status last verified
- Oct 2017
- First submitted
- 11 Apr 2011
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23523240
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01334268
- Acronym / sponsor ID
- R-China RCT / IP 10009066DOC
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Study start
- Sep 2011 (actual)
- Primary completion
- Nov 2012 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 13 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taxus Liberte Paclitaxel-Eluting Coronary Stent System | Active comparator | Device: Taxus Liberte Paclitaxel-Eluting Coronary Stent SystemSubjects will be randomized to be treated with Taxus Liberte Paclitaxel-Eluting Coronary Stent System by an interactive voice response system (IVRS). |
| Medtronic Resolute (Zotarolimus-eluting stent) | Experimental | Device: Resolute Zotarolimus-Eluting Coronary Stent SystemSubjects will be randomized to be treated with Medtronic Resolute (Zotarolimus-eluting stent) by an interactive voice response system (IVRS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taxus Liberte Paclitaxel-Eluting Coronary Stent SystemAlso: TaxusTaxus Liberte Paclitaxel-Eluting Coronary Stent System Implantation | Device | Taxus Liberte Paclitaxel-Eluting Coronary Stent System |
| Resolute Zotarolimus-Eluting Coronary Stent SystemAlso: ResoluteResolute Zotarolimus-Eluting Coronary Stent System Implantation | Device | Medtronic Resolute (Zotarolimus-eluting stent) |
Primary outcome
in-stent late lumen loss (LLL)
Time frame: 9 months
in-stent late lumen loss (LLL), defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiography MLD.
11 secondary outcomes
Device success
Time frame: at the end of the index procedure or during hospital stay
Death
Time frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Myocardial infarction
Time frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
MACE composite endpoint
Time frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Composite endpoint of (all cause) mortality, Myocardial Infarction (Q-wave and non Q-wave) or (any) revascularization
Time frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
All revascularizations
Time frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Target lesion failure (TLF)
Time frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Target vessel failure (TVF)
Time frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Stent thrombosis
Time frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Lesion success
Time frame: At the end of the index procedure or during hospital stay
Procedure success
Time frame: At the end of the index procedure or during hospital stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
- Results publication: PubMed 23523240Xu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuzheng Lv principal investigator
An Zhen Hospital
Yundai Chen principal investigator
Chinese PLA General Hospital
Zhimin Du principal investigator
First Affiliated Hospital, Sun Yat-Sen University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taxus Liberte Paclitaxel-Eluting Coronary Stent System and Resolute Zotarolimus-Eluting Coronary Stent System in people with Ischemic Heart Disease and Stenotic Coronary Lesion, run by Medtronic Vascular at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
in-stent late lumen loss (LLL) (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01334268, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2017.