RESOLUTE China RCT

Medtronic Vascular400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

400

Conditions

Ischemic Heart Disease Stenotic Coronary Lesion Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease

Interventions

Taxus Liberte Paclitaxel-Eluting Coronary Stent SystemDEVICE

Taxus Liberte Paclitaxel-Eluting Coronary Stent System Implantation

Resolute Zotarolimus-Eluting Coronary Stent SystemDEVICE

Resolute Zotarolimus-Eluting Coronary Stent System Implantation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

An Zhen Hospital

Beijing, Beijing Municipality, China

Beijing Fu Wai Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

First Affiliated Hospital of Medical College of XI'AN Jiaotong University

Xi'an, Shaanxi, China

Outcomes

Primary Outcomes

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.

Time frame: 9 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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

Data from ClinicalTrials.gov

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