An observational study in Ischemic Heart Disease, Stenotic Coronary Lesion and Cardiovascular Diseases, sponsored by Medtronic Vascular. Completed at 6 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-05.
Sponsored by Medtronic Vascular · Observational
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.
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 1,800 is above the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Medtronic Vascular is the lead sponsor of 58 studies on the registry; 7 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Patient must meet all of the following criteria to be eligible for treatment in the trial:
Exclusion Criteria:
Patients will be excluded from the trial if any of the following criteria are met:
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.
Time frame: 12m
Overall stent thrombosis
Overall stent thrombosis, defined as definite and probable stent thrombosis, according to the Academic Research Consortium (ARC) definition, at 1 year.
Time frame: 12m
Device success, Lesion success, Procedural success
Time frame: 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
Time frame: 30 days, 6 months, 2 year, 3 year, 4 year and 5 year
All deaths (cardiac, vascular and non-cardiovascular)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Significant bleeding complications and stroke
hemorrhagic in nature
Time frame: 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
Time frame: 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
Time frame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Medtronic Vascular