RESOLUTE China Registry: (R-C Registry)

Evaluation of the Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in a Real-World Patient Population in China

To document the safety and overall clinical performance of the Resolute Zotarolimus-Eluting Coronary Stent System in a real-world patient population requiring stent implantation.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Coronary Artery Disease; Arteriosclerosis; Ischemic Heart Disease; Stenotic Coronary Lesion

Detailed Description

The Resolute stent is designed to support the approach of delivering drug to the coronary arterial tissue over a longer period of time than that offered by current approved DES products. This method of prolonged drug elution may address the need to control local vascular neointimal proliferation in patients with complex lesions for extended therapeutic effect. The purpose of this multi-center trial is to investigate the clinical safety and efficacy of the Endeavor Resolute drug-eluting stent in every-day patients, like stable and unstable patients with single or multi-vessel disease and/or complex lesions.

Patients should be treated according to normal hospital routine practice and in line with the applicable guidelines on percutaneous coronary interventions and the Instructions For Use of the device.

1800 patients will be enrolled from China at approximately 40 centers where Endeavor Resolute stent is commercially available.

• Study Type: Observational
• Enrollment (Actual): 1800

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100000
    • Beijing Fumwai Hospital
  • Beijing, China, 100044
    • Peiking University People's Hospital
  • Fuzhou, China, 350001
    • Fujian Medical University Union Hospital
  • Guangdong, China, 510000
    • Guangdong Provincial People's Hospital
  • Nanjing, China, 210006
    • Nanjing First Hospital
  • Wuhan, China, 430022
    • Wuhan Asia Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients suitable for drug-eluting stent implantation according to the applicable guidelines on percutaneous coronary interventions and the Instructions for Use of the Resolute Zotarolimus-Eluting Coronary Stent System.

All consecutive patients eligible for drug-eluting stent implantation with the elective use of the Resolute stent in one or more target lesions are candidates to be enrolled.

Description

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 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
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, polymer coatings (e.g. Biolinx), zotarolimus, 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 Registry

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target lesion failure (TLF)	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 at 1 year.	12m

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall stent thrombosis	Overall stent thrombosis, defined as definite and probable stent thrombosis, according to the Academic Research Consortium (ARC) definition, at 1 year.	12m
Device success, Lesion success, Procedural success		At the end of the index procedure or during hospital stay
TLF	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 will be assessed at 30 days, 6 months, 2 year, 3 year, 4 year and 5 year	30 days, 6 months, 2 year, 3 year, 4 year and 5 year
All deaths (cardiac, vascular and non-cardiovascular)		30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Stent thrombosis rate	defined as definite, probable, possible, and overall stent thrombosis (according to ARC definition)	at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Myocardial infarction	Q wave and non-Q wave MI	at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Revascularization	target lesion and target vessel revascularization (TLR and TVR)	at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Significant bleeding complications and stroke	hemorrhagic in nature	at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Target vessel failure (TVF)	a composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization	at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Major adverse cardiac events (MACE)	a composite endpoint of death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or repeat target lesion revascularization (clinically driven/clinically indicated) by percutaneous or surgical methods	at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year

Collaborators and Investigators

• Sponsor: Medtronic Vascular
• Investigators: Principal Investigator: Jiyan Chen, MD, Guangdong Provincial People's Hospital; Principal Investigator: Shubin Qiao, MD, Fu Wai Hospital, Beijing, China; Principal Investigator: Lianglong Chen, MD, Fujian Medical University Union Hospital; Principal Investigator: Shaoliang Chen, MD, The First Affiliated Hospital with Nanjing Medical University; Principal Investigator: Weimin Wang, MD, Peiking University People's Hospital; Principal Investigator: Guoying Zhu, MD, Wuhan Asia Heart Hospital

Publications and helpful links

General Publications

• Qiao S, Chen L, Chen S, Wang W, Zhu G. One-year outcomes from an all-comers chinese population of patients implanted with the resolute zotarolimus-eluting stent. Am J Cardiol. 2014 Feb 15;113(4):613-20. doi: 10.1016/j.amjcard.2013.10.042. Epub 2013 Nov 23.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2010
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): December 15, 2017

Study Registration Dates

• First Submitted: November 17, 2010
• First Submitted That Met QC Criteria: November 17, 2010
• First Posted (Estimate): November 18, 2010

Study Record Updates

• Last Update Posted (Actual): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 4, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Stent Thrombosis; Percutaneous Coronary Intervention (PCI); Target Vessel Revascularization (TVR); Target Lesion Revascularization (TLR); Myocardial Infarction (MI); Target Vessel Failure (TVF); Target Lesion Failure (TLF); Restenotic Lesion; Real-world
• Additional Relevant MeSH Terms: Vascular Diseases; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis
• Other Study ID Numbers: IP124