Clinical trial NCT01334268: RESOLUTE 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2011-04-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: in-stent late lumen loss (LLL)
timeFrame: 9 months
Secondary outcomes:
measure: Device success
timeFrame: at the end of the index procedure or during hospital stay
measure: Death
timeFrame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
measure: Myocardial infarction
timeFrame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
measure: MACE composite endpoint
timeFrame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
measure: Composite endpoint of (all cause) mortality, Myocardial Infarction (Q-wave and non Q-wave) or (any) revascularization
timeFrame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
measure: All revascularizations
timeFrame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
measure: Target lesion failure (TLF)
timeFrame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
measure: Target vessel failure (TVF)
timeFrame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
measure: Stent thrombosis
timeFrame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
measure: Lesion success
timeFrame: At the end of the index procedure or during hospital stay
measure: Procedure success
timeFrame: At the end of the index procedure or during hospital stay
Other outcomes:
Locations:
city: Beijing
country: China
facility: An Zhen Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Fu Wai Hospital
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Xi'an
country: China
facility: First Affiliated Hospital of Medical College of XI'AN Jiaotong University
state: Shaanxi
Study officials:
affiliation: An Zhen Hospital
name: Shuzheng Lv
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese PLA General Hospital
name: Yundai Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Zhimin Du
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Fu Wai Hospital
name: Bo Xu
role: PRINCIPAL_INVESTIGATOR
affiliation: Fu Wai Hospital, Beijing, China
name: Yuejin Yang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Medical College of ZI'AN Jiaotong University
name: Zuyi Yuan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.