- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07455747
Reell behandling av ekstrakraniell karotisarteriesykdom med ENROUTE™ Transcarotid Neuroprotection System (ENTRUST)
Reell behandling av ekstrakraniell karotisarteriesykdom med ENROUTE™ Transcarotid Neuroproteksjonssystem (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.
Studieoversikt
Status
Detaljert 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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Erin Hammer
- Telefonnummer: 952-356-2730
- E-post: Erin.Hammer@bsci.com
Studiesteder
-
-
Missouri
-
St Louis, Missouri, Forente stater, 63141
- Rekruttering
- St. Luke's Episcopal-Presbyterian Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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:
-
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 studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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)
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Angela H Martin, MD, Evansville Surgical Associates
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- S10071
Plan for individuelle deltakerdata (IPD)
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