Overview

This trial is active, not recruiting.

Conditions ischemic heart disease, stenotic coronary lesion, cardiovascular diseases, arteriosclerosis, coronary artery disease
Treatments taxus liberte paclitaxel-eluting coronary stent system, resolute zotarolimus-eluting coronary stent system
Sponsor Medtronic Vascular
Start date September 2011
End date November 2012
Trial size 400 participants
Trial identifier NCT01334268, IP 10009066DOC

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Subjects will be randomized to be treated with Taxus Liberte Paclitaxel-Eluting Coronary Stent System by an interactive voice response system (IVRS).
taxus liberte paclitaxel-eluting coronary stent system Taxus
Taxus Liberte Paclitaxel-Eluting Coronary Stent System Implantation
(Experimental)
Subjects will be randomized to be treated with Medtronic Resolute (Zotarolimus-eluting stent) by an interactive voice response system (IVRS).
resolute zotarolimus-eluting coronary stent system Resolute
Resolute Zotarolimus-Eluting Coronary Stent System Implantation

Primary Outcomes

Measure
in-stent late lumen loss (LLL)
time frame: 9 months

Secondary Outcomes

Measure
Device success
time frame: at the end of the index procedure or during hospital stay
Death
time frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Myocardial infarction
time frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
MACE composite endpoint
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
time frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
All revascularizations
time frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Target lesion failure (TLF)
time frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Target vessel failure (TVF)
time frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Stent thrombosis
time frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Lesion success
time frame: At the end of the index procedure or during hospital stay
Procedure success
time frame: At the end of the index procedure or during hospital stay

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Shuzheng Lv
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Medtronic Vascular.