RESOLUTE China Registry: (R-C Registry)
4 april 2018 uppdaterad av: Medtronic Vascular
Evaluation of the Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in a Real-World Patient Population in China
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.
Studieöversikt
Status
Avslutad
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
1800
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Beijing, Kina, 100000
- Beijing Fumwai Hospital
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Beijing, Kina, 100044
- Peiking University People's Hospital
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Fuzhou, Kina, 350001
- Fujian Medical University Union Hospital
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Guangdong, Kina, 510000
- Guangdong Provincial People's Hospital
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Nanjing, Kina, 210006
- Nanjing First Hospital
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Wuhan, Kina, 430022
- Wuhan Asia Heart Hospital
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
Inclusion Criteria:
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
Exclusion Criteria:
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Endast fall
- Tidsperspektiv: Blivande
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Target lesion failure (TLF)
Tidsram: 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.
|
12m
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall stent thrombosis
Tidsram: 12m
|
Overall stent thrombosis, defined as definite and probable stent thrombosis, according to the Academic Research Consortium (ARC) definition, at 1 year.
|
12m
|
|
Device success, Lesion success, Procedural success
Tidsram: At the end of the index procedure or during hospital stay
|
At the end of the index procedure or during hospital stay
|
|
|
TLF
Tidsram: 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
|
30 days, 6 months, 2 year, 3 year, 4 year and 5 year
|
|
All deaths (cardiac, vascular and non-cardiovascular)
Tidsram: 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
|
30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
|
|
|
Stent thrombosis rate
Tidsram: 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)
|
at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
|
|
Myocardial infarction
Tidsram: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
|
Q wave and non-Q wave MI
|
at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
|
|
Revascularization
Tidsram: 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)
|
at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
|
|
Significant bleeding complications and stroke
Tidsram: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
|
hemorrhagic in nature
|
at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
|
|
Target vessel failure (TVF)
Tidsram: 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
|
at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
|
|
Major adverse cardiac events (MACE)
Tidsram: 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
|
at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Jiyan Chen, MD, Guangdong Provincial People's Hospital
- Huvudutredare: Shubin Qiao, MD, Fu Wai Hospital, Beijing, China
- Huvudutredare: Lianglong Chen, MD, Fujian Medical University Union Hospital
- Huvudutredare: Shaoliang Chen, MD, The First Affiliated Hospital with Nanjing Medical University
- Huvudutredare: Weimin Wang, MD, Peiking University People's Hospital
- Huvudutredare: Guoying Zhu, MD, Wuhan Asia Heart Hospital
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 december 2010
Primärt slutförande (Faktisk)
1 april 2013
Avslutad studie (Faktisk)
15 december 2017
Studieregistreringsdatum
Först inskickad
17 november 2010
Först inskickad som uppfyllde QC-kriterierna
17 november 2010
Första postat (Uppskatta)
18 november 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 april 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 april 2018
Senast verifierad
1 april 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IP124
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