RESOLUTE China Registry:

Coronary Artery Disease Clinical Trial

— R-C Registry  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01243749
• Other study ID #: IP124
• Status: Completed
• First received: November 17, 2010
• Last updated: April 4, 2018
• Start date: December 2010
• Est. completion date: December 15, 2017

Study information

• Verified date: April 2018
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: December 15, 2017
• Est. primary completion date: April 2013
• 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 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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Beijing Fumwai Hospital	Beijing
China	Peiking University People's Hospital	Beijing
China	Fujian Medical University Union Hospital	Fuzhou
China	Guangdong Provincial People's Hospital	Guangdong
China	Nanjing First Hospital	Nanjing
China	Wuhan Asia Heart Hospital	Wuhan

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Country where clinical trial is conducted

China, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Device success, Lesion success, Procedural success		At the end of the index procedure or during hospital stay
Secondary	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
Secondary	All deaths (cardiac, vascular and non-cardiovascular)		30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Secondary	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
Secondary	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
Secondary	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
Secondary	Significant bleeding complications and stroke	hemorrhagic in nature	at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Secondary	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
Secondary	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