RESOLUTE China RCT

Coronary Artery Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01334268
• Other study ID #: IP 10009066DOC
• Status: Completed
• Phase: N/A
• First received: April 11, 2011
• Last updated: October 16, 2017
• Start date: September 2011
• Est. completion date: June 30, 2017

Study information

• Verified date: October 2017
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 30, 2017
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriosclerosis
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia
• Stenotic Coronary Lesion

Intervention

Device:
• 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

Locations

Country	Name	City	State
China	An Zhen Hospital	Beijing	Beijing
China	Beijing Fu Wai Hospital	Beijing	Beijing
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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Country where clinical trial is conducted

China, 

References & Publications (1)

Xu B, Yang Y, Yuan Z, Du Z, Wong SC, Généreux 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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	9 months
Secondary	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.	at the end of the index procedure or during hospital stay
Secondary	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.	30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Secondary	Myocardial infarction	All myocardial infarction data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions.	30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Secondary	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.	30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Secondary	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.	30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Secondary	All revascularizations	Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR.	30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Secondary	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.	30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Secondary	Target vessel failure (TVF)	A composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization(TVR.	30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Secondary	Stent thrombosis	As determined by Medtronic historic and ARC definitions.	30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr
Secondary	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.	At the end of the index procedure or during hospital stay
Secondary	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.	At the end of the index procedure or during hospital stay