Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
400 participants
INTERVENTIONAL
2011-09-30
2017-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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).
Taxus Liberte Paclitaxel-Eluting Coronary Stent System
Taxus Liberte Paclitaxel-Eluting Coronary Stent System Implantation
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).
Resolute Zotarolimus-Eluting Coronary Stent System
Resolute Zotarolimus-Eluting Coronary Stent System Implantation
Interventions
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Taxus Liberte Paclitaxel-Eluting Coronary Stent System
Taxus Liberte Paclitaxel-Eluting Coronary Stent System Implantation
Resolute Zotarolimus-Eluting Coronary Stent System
Resolute Zotarolimus-Eluting Coronary Stent System Implantation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Medtronic Vascular
INDUSTRY
Responsible Party
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Principal Investigators
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Shuzheng Lv
Role: PRINCIPAL_INVESTIGATOR
An Zhen Hospital
Yundai Chen
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Zhimin Du
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital, Sun Yat-Sen University
Bo Xu
Role: PRINCIPAL_INVESTIGATOR
Beijing Fu Wai Hospital
Yuejin Yang, MD
Role: PRINCIPAL_INVESTIGATOR
Fu Wai Hospital, Beijing, China
Zuyi Yuan
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Medical College of ZI'AN Jiaotong University
Locations
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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
Countries
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References
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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.
Other Identifiers
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IP 10009066DOC
Identifier Type: -
Identifier Source: org_study_id