Klinische proef op Hart-en vaatziekten, Coronaire hartziekte, Arteriosclerose, Ischemische hartziekte, Stenotische coronaire laesie - Register voor klinische proeven

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

1800

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

China
- - Beijing, China, 100000
    - Beijing Fumwai Hospital
  - Beijing, China, 100044
    - Peiking University People's Hospital
  - Fuzhou, China, 350001
    - Fujian Medical University Union Hospital
  - Guangdong, China, 510000
    - Guangdong Provincial People's Hospital
  - Nanjing, China, 210006
    - Nanjing First Hospital
  - Wuhan, China, 430022
    - Wuhan Asia Heart Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Observatiemodellen: Case-Alleen
Tijdsperspectieven: Prospectief

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Target lesion failure (TLF) Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Overall stent thrombosis Tijdsspanne: 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 Tijdsspanne: At the end of the index procedure or during hospital stay		At the end of the index procedure or during hospital stay
TLF Tijdsspanne: 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) Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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) Tijdsspanne: 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) Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Medtronic Vascular

Onderzoekers

Hoofdonderzoeker: Jiyan Chen, MD, Guangdong Provincial People's Hospital
Hoofdonderzoeker: Shubin Qiao, MD, Fu Wai Hospital, Beijing, China
Hoofdonderzoeker: Lianglong Chen, MD, Fujian Medical University Union Hospital
Hoofdonderzoeker: Shaoliang Chen, MD, The First Affiliated Hospital with Nanjing Medical University
Hoofdonderzoeker: Weimin Wang, MD, Peiking University People's Hospital
Hoofdonderzoeker: Guoying Zhu, MD, Wuhan Asia Heart Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Qiao S, Chen L, Chen S, Wang W, Zhu G. One-year outcomes from an all-comers chinese population of patients implanted with the resolute zotarolimus-eluting stent. Am J Cardiol. 2014 Feb 15;113(4):613-20. doi: 10.1016/j.amjcard.2013.10.042. Epub 2013 Nov 23.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 december 2010

Primaire voltooiing (Werkelijk)

1 april 2013

Studie voltooiing (Werkelijk)

15 december 2017

Studieregistratiedata

Eerst ingediend

17 november 2010

Eerst ingediend dat voldeed aan de QC-criteria