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
  Purpose

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.


Condition Intervention
Ischemic Heart Disease
Stenotic Coronary Lesion
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease
Device: Taxus Liberte Paclitaxel-Eluting Coronary Stent System
Device: Resolute Zotarolimus-Eluting Coronary Stent System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



Enrollment: 400
Study Start Date: September 2011
Estimated Study Completion Date: December 2017
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Taxus
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 Name: Resolute

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01334268

Locations
China, Beijing
An Zhen Hospital
Beijing, Beijing, China, 100029
Beijing Fu Wai Hospital
Beijing, Beijing, China, 100037
China, Guangdong
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
China, Shaanxi
First Affiliated Hospital of Medical College of XI'AN Jiaotong University
Xi'an, Shaanxi, China, 710061
Sponsors and Collaborators
Medtronic Vascular
Investigators
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
  More Information

No publications provided by Medtronic Vascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT01334268     History of Changes
Other Study ID Numbers: IP 10009066DOC
Study First Received: April 11, 2011
Last Updated: October 21, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Medtronic Vascular:
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

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arteriosclerosis
Atherosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Paclitaxel
Sirolimus
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014