RESOLUTE China RCT (R-China RCT)

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Coronary Artery Disease; Arteriosclerosis; Ischemic Heart Disease; Stenotic Coronary Lesion
• Intervention / Treatment: Device: Taxus Liberte Paclitaxel-Eluting Coronary Stent System; Device: Resolute Zotarolimus-Eluting Coronary Stent System

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 Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • An Zhen Hospital
    • Beijing, Beijing, China, 100037
      • Beijing Fu Wai Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The first Affiliated Hospital, Sun Yat-Sen University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Device: Taxus Liberte Paclitaxel-Eluting Coronary Stent System; Taxus Liberte Paclitaxel-Eluting Coronary Stent System Implantation; Other Names: Taxus
Experimental: 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).	Device: Resolute Zotarolimus-Eluting Coronary Stent System; Resolute Zotarolimus-Eluting Coronary Stent System Implantation; Other Names: Resolute

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
All revascularizations	Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR.	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.	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.	30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Stent thrombosis	As determined by Medtronic historic and ARC definitions.	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.	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.	At the end of the index procedure or during hospital stay

Collaborators and Investigators

• Sponsor: Medtronic Vascular
• Investigators: Principal Investigator: Shuzheng Lv, An Zhen 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, Fu Wai Hospital, Beijing, China; Principal Investigator: Zuyi Yuan, First Affiliated Hospital of Medical College of ZI'AN Jiaotong University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: April 11, 2011
• First Submitted That Met QC Criteria: April 12, 2011
• First Posted (Estimate): April 13, 2011

Study Record Updates

• Last Update Posted (Actual): October 18, 2017
• Last Update Submitted That Met QC Criteria: October 16, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: PERCUTANEOUS CORONARY INTERVENTION (PCI); In-stent Late Lumen Loss (LLL); MYOCARDIAL INFARCTION (MI); TARGET VESSEL REVASCULARIZATION (TVR); TARGET LESION REVASCULARIZATION (TLR); STENT THROMBOSIS; TARGET LESION FAILURE (TLF); TARGET VESSEL FAILURE (TVF); RESTENOTIC LESION; REAL-WORLD; THE RANDOMIZED CONTROLLED TRIAL
• Additional Relevant MeSH Terms: Vascular Diseases; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: IP 10009066DOC