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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

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:

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

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

NCT ID

NCT01334268

First Posted

April 11, 2011

Last Updated

October 16, 2017

Sponsor

Medtronic Vascular

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

Time Frame

at the end of the index procedure or during hospital stay

Title

Death

Description

Time Frame