- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07455747
Real-World-behandling af ekstrakraniel karotisarteriesygdom med ENROUTE™ Transcarotid Neuroprotection System (ENTRUST)
Real-World behandling af ekstrakraniell carotisarteriesygdom med ENROUTE™ Transcarotid Neurobeskyttelsessystemet (ENTRUST)
The ENTRUST registry's objective is to collect real-world data (RWD) and health economic data on the ENROUTE™ Transcarotid Neuroprotection System (ENROUTE™ Transcarotid NPS), including populations in which outcomes of Transcarotid Artery Revascularization (TCAR) in patients with extracranial carotid artery disease are inadequately reported.
Studieoversigt
Status
Detaljeret beskrivelse
A global prospective, single-arm, non-randomized, open-label, observational/non-interventional, multi-center registry to collect Real-World Data for TCAR procedure, including health economic data.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Erin Hammer
- Telefonnummer: 952-356-2730
- E-mail: Erin.Hammer@bsci.com
Studiesteder
-
-
Missouri
-
St Louis, Missouri, Forenede Stater, 63141
- Rekruttering
- St. Luke's Episcopal-Presbyterian Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
The intended population for the ENTRUST Registry are real-world patients who are treated with ENROUTE™ Transcarotid NPS in conjunction with any commercially available Boston Scientific stent marketed for treatment of carotid artery disease. Efforts will be made to include study centers with varied patient populations in order to enroll populations previously not represented in carotid artery disease trials.
Beskrivelse
Inclusion Criteria:
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Patient is ≥ 18 years of age*
-
Written informed consent (patient data-release form)
-
Use of ENROUTE™ Transcarotid Neuroprotection System in conjunction with any commercially available Boston Scientific stent marketed for treatment of carotid artery disease and specified in the Registry Enrollment Guide(s).
- Refer to the Registry Enrollment Guide for details on enrollment restrictions based on patient age
Exclusion Criteria:
- Life expectancy of < 1 year or patient is unlikely to derive net clinical benefit from carotid revascularization.
- Patient has primary, recurrent or metastatic malignancy and does not have independent assessment of life expectancy of ≥5 years performed by the treating oncologist or an appropriate specialist other than the physician performing TCAR.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Clinical Cohort
All enrolled patients are included in the Clinical Cohort. Patients will complete assessments per standard of care through 12-months in North America. |
ENROUTE™ Transcarotid NPS AND ENROUTE™ Transcarotid Stent System. Additionally, ENROUTE™ Transcarotid NPS AND any commercially available Boston Scientific stent marketed for treatment of carotid artery disease may be added upon commercial availability. |
|
Extended Clinical Cohort
Patients who elect to be followed through 36 months are included in the Extended Clinical Cohort. Patients will complete assessments per standard of care through 36-months in North America. |
ENROUTE™ Transcarotid NPS AND ENROUTE™ Transcarotid Stent System. Additionally, ENROUTE™ Transcarotid NPS AND any commercially available Boston Scientific stent marketed for treatment of carotid artery disease may be added upon commercial availability. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Major Adverse Events
Tidsramme: within 30 days (death, stroke, or MI); within 31-365 days (ipsilateral stroke)
|
Major Adverse Events (MAEs) defined as a composite outcome including any death, stroke, or myocardial infarction (MI) within 30 days of the index procedure and ipsilateral stroke within 31 days to 365 days of the index procedure. No pre-specified endpoints or formal tests of hypotheses are proposed. Analyses will be performed for exploratory purposes. |
within 30 days (death, stroke, or MI); within 31-365 days (ipsilateral stroke)
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Angela H Martin, MD, Evansville Surgical Associates
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- S10071
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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