Clinical trial NCT01243749: RESOLUTE China Registry:
Official title: Evaluation of the Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in a Real-World Patient Population in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Heart Disease
Stenotic Coronary Lesion
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease
Keywords: Target Vessel Revascularization (TVR)
Target Lesion Revascularization (TLR)
Myocardial Infarction (MI)
Target Vessel Failure (TVF)
Target Lesion Failure (TLF)
Stent Thrombosis
Restenotic Lesion
Percutaneous Coronary Intervention (PCI)
Real-world
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2010-11-18
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

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 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

Primary outcomes:
measure: Target lesion failure (TLF)
timeFrame: 12m
Secondary outcomes:
measure: Overall stent thrombosis
timeFrame: 12m
measure: Device success, Lesion success, Procedural success
timeFrame: At the end of the index procedure or during hospital stay
measure: TLF
timeFrame: 30 days, 6 months, 2 year, 3 year, 4 year and 5 year
measure: All deaths (cardiac, vascular and non-cardiovascular)
timeFrame: 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
measure: Stent thrombosis rate
timeFrame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
measure: Myocardial infarction
timeFrame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
measure: Revascularization
timeFrame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
measure: Significant bleeding complications and stroke
timeFrame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
measure: Target vessel failure (TVF)
timeFrame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
measure: Major adverse cardiac events (MACE)
timeFrame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Fumwai Hospital
city: Beijing
country: China
facility: Peiking University People's Hospital
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
city: Guangdong
country: China
facility: Guangdong Provincial People's Hospital
city: Nanjing
country: China
facility: Nanjing First Hospital
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
Study officials:
affiliation: Fu Wai Hospital, Beijing, China
name: Shubin Qiao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangdong Provincial People's Hospital
name: Jiyan Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fujian Medical University Union Hospital
name: Lianglong Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Shaoliang Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peiking University People's Hospital
name: Weimin Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuhan Asia Heart Hospital
name: Guoying Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.