RESOLUTE China Registry: (R-C Registry)
4. April 2018 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
1800
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Beijing, China, 100000
- Beijing Fumwai Hospital
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Beijing, China, 100044
- Peiking University People's Hospital
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Fuzhou, China, 350001
- Fujian Medical University Union Hospital
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Guangdong, China, 510000
- Guangdong Provincial People's Hospital
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Nanjing, China, 210006
- Nanjing First Hospital
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Wuhan, China, 430022
- Wuhan Asia Heart Hospital
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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.
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Nur Fall
- Zeitperspektiven: Interessent
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Target lesion failure (TLF)
Zeitfenster: 12m
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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.
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12m
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Overall stent thrombosis
Zeitfenster: 12m
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Overall stent thrombosis, defined as definite and probable stent thrombosis, according to the Academic Research Consortium (ARC) definition, at 1 year.
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12m
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Device success, Lesion success, Procedural success
Zeitfenster: At the end of the index procedure or during hospital stay
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At the end of the index procedure or during hospital stay
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TLF
Zeitfenster: 30 days, 6 months, 2 year, 3 year, 4 year and 5 year
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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
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30 days, 6 months, 2 year, 3 year, 4 year and 5 year
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All deaths (cardiac, vascular and non-cardiovascular)
Zeitfenster: 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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Stent thrombosis rate
Zeitfenster: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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defined as definite, probable, possible, and overall stent thrombosis (according to ARC definition)
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at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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Myocardial infarction
Zeitfenster: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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Q wave and non-Q wave MI
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at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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Revascularization
Zeitfenster: 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)
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at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
|
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Significant bleeding complications and stroke
Zeitfenster: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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hemorrhagic in nature
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at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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Target vessel failure (TVF)
Zeitfenster: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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a composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization
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at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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Major adverse cardiac events (MACE)
Zeitfenster: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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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
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at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Jiyan Chen, MD, Guangdong Provincial People's Hospital
- Hauptermittler: Shubin Qiao, MD, Fu Wai Hospital, Beijing, China
- Hauptermittler: Lianglong Chen, MD, Fujian Medical University Union Hospital
- Hauptermittler: Shaoliang Chen, MD, The First Affiliated Hospital with Nanjing Medical University
- Hauptermittler: Weimin Wang, MD, Peiking University People's Hospital
- Hauptermittler: Guoying Zhu, MD, Wuhan Asia Heart Hospital
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Dezember 2010
Primärer Abschluss (Tatsächlich)
1. April 2013
Studienabschluss (Tatsächlich)
15. Dezember 2017
Studienanmeldedaten
Zuerst eingereicht
17. November 2010
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
17. November 2010
Zuerst gepostet (Schätzen)
18. November 2010
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
5. April 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
4. April 2018
Zuletzt verifiziert
1. April 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IP124
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