Post-Market Celect Platinum Vena Cava Filter og Gunther Tulip Retrieval Set Study
Post-Market Celect Platinum Vena Cava Filter og Günther Tulip Retrieval Set Study
This prospective, observational, post-market study will be performed to collect patient-level data on the Celect Platinum Vena Cava Filter Sets and the Günther Tulip Vena Cava Filter Retrieval Set to confirm continued safety and performance of the devices throughout their expected lifetime and continued acceptability of the benefit:risk ratio. Additionally, the study intends to evaluate longer-term (i.e., up to 5 years) outcome data while the filter is indwelling.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Sabina Andersen
- Telefonnummer: +45 29 73 41 34
- E-mail: sabina.hjorth@cookmedical.com
Studiesteder
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-
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Hull, Det Forenede Kongerige, HU3 2JZ
- Rekruttering
- Hull University Teaching Hospitals NHS Trust
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Liverpool, Det Forenede Kongerige, L7 8XP
- Rekruttering
- Royal Liverpool Hospital
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West Yorkshire
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Leeds, West Yorkshire, Det Forenede Kongerige, LS1 3EX
- Rekruttering
- Leeds Teaching Hospital NHS Trust
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California
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Los Angeles, California, Forenede Stater, 90048
- Rekruttering
- Cedars-Sinai Medical Center
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-
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Barcelona, Spanien, 08907
- Rekruttering
- Hospital Universitari de Bellvitage
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Córdoba, Spanien, 14004
- Rekruttering
- Hospital Reina Sofia de Cordoba
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Sabadell, Spanien, 08208
- Rekruttering
- Parc Tauli
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
A patient dataset is deemed suitable for inclusion in the study if the patient has a procedure where a Celect Platinum Vena Cava Filter
Beskrivelse
Inclusion Criteria:
- A patient dataset is deemed suitable for inclusion if the patient has a procedure where a Celect Platinum Vena Cava Filter is placed
- Subject has not previously participated in the Cook MDR-2126 study.
Exclusion Criteria:
- Patients will be excluded from enrollment if the patient or his/her legally authorized representative objects to collection and processing of his/her data or is not willing to sign the Informed Consent.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Patients indicated for the placement of a Celect Platinum Vena Cava Filter
Patients indicated for the placement of a Celect Platinum Vena Cava Filter |
Inferior vena cava filter |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Filter-related primary endpoint (safety)
Tidsramme: Index procedure through 12-months post procedure
|
Freedom from major adverse events through 12 months (365 ± 30 days), defined as clinically significant IVC penetration, migration of filter (>2 cm)/filter components, filter fracture, embolization of filter or filter fragments to the heart or lungs, IVC thrombotic occlusion, symptomatic deep vein thrombosis while a filter is indwelling, access site complications with clinical sequelae, and procedure/device-related death. |
Index procedure through 12-months post procedure
|
|
Filter-related primary endpoint (performance)
Tidsramme: 12-months post procedure
|
Performance: Technical placement success and freedom from symptomatic PE while a filter is indwelling through 12 months (365 ± 30 days).These values will be reported as aggregate. Technical placement success - Deployment of filter in a location suitable to provide sufficient mechanical protection against PE with no filter deformation, fracture, premature release, or clinical migration. |
12-months post procedure
|
|
Filter Retrieval-related primary endpoint
Tidsramme: Through 30-days post procedure
|
Freedom from major adverse events through 30 days post-procedure, defined as access site complications with clinical sequelae, and procedure/device-related death. |
Through 30-days post procedure
|
|
Filter Retrieval-related primary endpoint
Tidsramme: At the time of retrieval procedure
|
Technical retrieval success, defined as endovascular retrieval of complete filter. |
At the time of retrieval procedure
|
Samarbejdspartnere og efterforskere
Sponsor
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MDR-2126
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request immediately after approval or clearance of the product and ending 5 years after approval or clearance. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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