Arteriosclerosis, Cardiovascular Diseases, Coronary Artery Disease, Ischemic Heart Disease, Stenotic Coronary Lesion
Conditions
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
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.
Interventions
None listed
Sponsors
Medtronic Vascular
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 | 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) |
| 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. |
| 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) |
| Significant bleeding complications and stroke | at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year | hemorrhagic in nature |
| 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 |
| 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 |
| 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 |
Countries
China
Outcome results
None listed