RESOLUTE China Registry:
- Conditions
- ArteriosclerosisIschemic Heart DiseaseStenotic Coronary LesionCardiovascular DiseasesCoronary Artery Disease
- Registration Number
- NCT01243749
- Lead Sponsor
- Medtronic Vascular
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1800
Patient must meet all of the following criteria to be eligible for treatment in the trial:
- Age ≥ 18 years or minimum age as required by local regulations
- 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
- 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
- Intention to electively implant at least one Resolute stent
- The patient is willing and able to cooperate with study procedures and required follow up visits
Patients will be excluded from the trial if any of the following criteria are met:
- 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
- Women with known pregnancy or who are lactating
- High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
- Currently participating in another trial that has not completed the primary endpoint or that clinically interferes with the current trial requirements
- Planned surgery within 6 months of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period
- Previous enrollment in the Resolute China Registry
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Target lesion failure (TLF) 12m 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.
- Secondary Outcome Measures
Name Time Method Device success, Lesion success, Procedural success At the end of the index procedure or during hospital stay TLF 30 days, 6 months, 2 year, 3 year, 4 year and 5 year 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
Revascularization at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year target lesion and target vessel revascularization (TLR and TVR)
Target vessel failure (TVF) at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year a composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization
Overall stent thrombosis 12m Overall stent thrombosis, defined as definite and probable stent thrombosis, according to the Academic Research Consortium (ARC) definition, at 1 year.
Stent thrombosis rate at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year defined as definite, probable, possible, and overall stent thrombosis (according to ARC definition)
All deaths (cardiac, vascular and non-cardiovascular) 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year Myocardial infarction at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year Q wave and non-Q wave MI
Significant bleeding complications and stroke at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year hemorrhagic in nature
Major adverse cardiac events (MACE) at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year 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
Trial Locations
- Locations (6)
Beijing Fumwai Hospital
🇨🇳Beijing, China
Peiking University People's Hospital
🇨🇳Beijing, China
Guangdong Provincial People's Hospital
🇨🇳Guangdong, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, China
Wuhan Asia Heart Hospital
🇨🇳Wuhan, China
Nanjing First Hospital
🇨🇳Nanjing, China