Resolute Zotarolimus-Eluting Stent Versus the Taxus Liberte Paclitaxel-Eluting Stent for Percutaneous Coronary Intervention in China (R-China RCT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT01334268
First received: April 11, 2011
Last updated: October 21, 2013
Last verified: October 2013

April 11, 2011
October 21, 2013
September 2011
November 2012   (final data collection date for primary outcome measure)
in-stent late lumen loss (LLL) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
in-stent late lumen loss (LLL), defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiography MLD.
Target vessel failure (TVF) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Target vessel failure (TVF), defined as composite of cardiac death, target vessel myocardial infarction or clinically-driven target vessel revascularization.
Complete list of historical versions of study NCT01334268 on ClinicalTrials.gov Archive Site
  • Device success [ Time Frame: at the end of the index procedure or during hospital stay ] [ Designated as safety issue: No ]

    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 [ Time Frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr ] [ Designated as safety issue: Yes ]
    All myocardial infarction data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions.
  • MACE composite endpoint [ Time Frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr ] [ Designated as safety issue: Yes ]
    Mortality, Myocardial Infarction (Q-wave and non Q wave) or (any) revascularization.
  • All revascularizations [ Time Frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr ] [ Designated as safety issue: Yes ]
    Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR.
  • Target lesion failure (TLF) [ Time Frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr ] [ Designated as safety issue: No ]
    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) [ Time Frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr ] [ Designated as safety issue: No ]
    A composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization(TVR.
  • Stent thrombosis [ Time Frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr ] [ Designated as safety issue: Yes ]
    As determined by Medtronic historic and ARC definitions.
  • Lesion success [ Time Frame: At the end of the index procedure or during hospital stay ] [ Designated as safety issue: No ]

    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 [ Time Frame: At the end of the index procedure or during hospital stay ] [ Designated as safety issue: No ]

    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.

  • Device success, Lesion success, Procedural success [ Time Frame: at the end of the index procedure or during hospital stay ] [ Designated as safety issue: No ]

    Device success-Using only assigned device, <50% residual stenosis of the target lesion (TL) or <30% residual stenosis by QCA (or <20% by visual assessment) AND TIMI flow 3 after procedure.

    Lesion success-Using any percutaneous method, <50% residual stenosis of the TL or <30% residual stenosis by QCA (or <20% by visual assessment) AND TIMI flow 3 after procedure.

    Procedure success-Using any percutaneous method, <50% residual stenosis of the TL or <30% residual stenosis by QCA (or <20% by visual assessment) AND TIMI flow 3 after procedure, and no in-hospital MACE.

  • Death [ Time Frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr ] [ Designated as safety issue: Yes ]
    All myocardial infarction data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions.
  • MACE composite endpoint [ Time Frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr ] [ Designated as safety issue: Yes ]
    Mortality, Myocardial Infarction (Q-wave and non Q wave) or (any) revascularization.
  • All revascularizations [ Time Frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr ] [ Designated as safety issue: Yes ]
    Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR.
  • Target lesion failure (TLF) [ Time Frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr ] [ Designated as safety issue: No ]
    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) [ Time Frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr ] [ Designated as safety issue: No ]
    A composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization(TVR.
  • Stent thrombosis [ Time Frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr ] [ Designated as safety issue: Yes ]
    As determined by Medtronic historic and ARC definitions.
Not Provided
Not Provided
 
Resolute Zotarolimus-Eluting Stent Versus the Taxus Liberte Paclitaxel-Eluting Stent for Percutaneous Coronary Intervention in China
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

A total of 400 subjects suitable for drug-eluting stent implantation according to the applicable guidelines on percutaneous coronary interventions and the Instructions for Use of the Resolute Zotarolimus-Eluting Coronary Stent System and Taxus Liberte Paclitaxel-Eluting Coronary Stent System.

  • Ischemic Heart Disease
  • Stenotic Coronary Lesion
  • Cardiovascular Diseases
  • Arteriosclerosis
  • Coronary Artery Disease
  • Device: Taxus Liberte Paclitaxel-Eluting Coronary Stent System
    Taxus Liberte Paclitaxel-Eluting Coronary Stent System Implantation
    Other Name: Taxus
  • Device: Resolute Zotarolimus-Eluting Coronary Stent System
    Resolute Zotarolimus-Eluting Coronary Stent System Implantation
    Other Name: Resolute
  • Taxus Liberte Paclitaxel-Eluting Coronary Stent System
    Subjects will be randomized to be treated with Taxus Liberte Paclitaxel-Eluting Coronary Stent System by an interactive voice response system (IVRS).
    Intervention: Device: Taxus Liberte Paclitaxel-Eluting Coronary Stent System
  • Medtronic Resolute (Zotarolimus-eluting stent)
    Subjects will be randomized to be treated with Medtronic Resolute (Zotarolimus-eluting stent) by an interactive voice response system (IVRS).
    Intervention: Device: Resolute Zotarolimus-Eluting Coronary Stent System
Xu B, Yang Y, Yuan Z, Du Z, Wong SC, Généreux 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
400
December 2017
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01334268
IP 10009066DOC
Yes
Medtronic Vascular
Medtronic Vascular
Not Provided
Principal Investigator: Shuzheng Lv An Zhen Hospital
Principal Investigator: Yundai Chen Chinese PLA General Hospital
Principal Investigator: Zhimin Du First Affiliated Hospital, Sun Yat-Sen University
Principal Investigator: Bo Xu Beijing Fu Wai Hospital
Principal Investigator: Yuejin Yang, MD Beijing Fuwai Hospital
Principal Investigator: Zuyi Yuan First Affiliated Hospital of Medical College of ZI'AN Jiaotong University
Medtronic Vascular
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP