- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00605332
Crux Biomedical IVC Filter - Evaluation of the Crux Inferior Vena Cava Filter System (Retrieve) (Retrieve)
3. august 2012 opdateret af: Crux Biomedical
Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System - ("Retrieve")
This is an open label, non-randomized, prospective, multicenter study.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
88
Fase
- Fase 2
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
Patients for this study must meet the following inclusion criteria to be eligible for enrollment:
- The patient is >18 years of age.
Patient is considered a candidate for the IVCF under one of the following indications:
- Proven PE
- Recurrent PE despite adequate anticoagulation
- Contraindication to anticoagulation
- Inability to achieve/maintain therapeutic anticoagulation
- Iliocaval DVT
- Large, free-floating proximal (i.e. ileofemoral) DVT
- Massive PE treated with thrombolysis/thrombectomy
- Chronic PE treated with thrombectomy
- Protection during thrombolysis for iliocaval DVT
- PE with limited cardiopulmonary reserve
- Poor compliance with anticoagulant medications
- High risk of injury worsened by anticoagulation (e.g., ataxia, falls)
- Multi-trauma patient with high risk of PE
- Surgical patients at high risk of PE
- Medical condition with high risk of PE
- Patient has a vena cava diameter of 17-28mm.
- The patient or legal guardian has been informed of the nature of the study and agrees to its provisions and has provided informed written consent.
- The patient is willing to be available for the appropriate follow-up for the duration of the study.
- The patient has suitable IVC anatomy that would allow infra-renal placement of the filter.
Exclusion Criteria:
Patients who have ANY of the following exclusion criteria are NOT eligible for the study:
The patient has one of the following conditions:
- Renal vein thrombosis
- IVC thrombosis extending to renal veins
- Duplicate IVC
- Gonadal vein thrombosis
- Requires supra-renal filter placement
- The patient has an uncontrolled infectious disease.
- The patient is at risk for aseptic PE.
- Patient has uncontrollable coagulopathy.
- Patient has an existing IVCF.
- The patient has a life expectancy of less than 6 months.
- The patient is pregnant.
- The patient has a condition that inhibits radiographic visualization of the IVC.
- The patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE) or Nitinol.
- The patient has a known hypersensitivity to contrast which cannot be pre-treated.
- The patient's access vessels preclude safe insertion of the delivery system.
- The patient is participating in another device or drug study. Patient must have completed the follow- up phase of any previous study at least 30 days prior to enrollment into this trial. The patient may only be enrolled in this study once.
- The patient is unable and/or unwilling to cooperate with study procedures or required follow-up visits.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 1
Investigative Device (Crux Biomedical IVC Filter) will be evaluated for its ability to capture thrombus for the prevention of pulmonary embolism.
|
Crux Biomedical IVC Filter
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Primary Efficacy Objective: To describe the clinical utility of the Crux IVCF by the following criteria: Absence of a recurrent PE and IVC thrombosis related to the Crux IVCF.
Tidsramme: 30 days post implant, 30 days post retrieval. Patients with indwelling filters will return 1 and 6 months post implant procedure.
|
30 days post implant, 30 days post retrieval. Patients with indwelling filters will return 1 and 6 months post implant procedure.
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Primary Safety Objective: To estimate the proportion of patients who experience device/procedure related complications associated with the Crux IVCF.
Tidsramme: 30 days post implant procedure and 30 days post retrieval procedure. Patients with indwelling filters will return 1 and 6 months post implant procedure.
|
30 days post implant procedure and 30 days post retrieval procedure. Patients with indwelling filters will return 1 and 6 months post implant procedure.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: David Rosenthal, MD, Atlanta Vascular Specialists
- Studieleder: Mel Schatz, Crux Biomedical
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2007
Primær færdiggørelse (Faktiske)
1. juli 2008
Studieafslutning (Faktiske)
1. juli 2009
Datoer for studieregistrering
Først indsendt
2. januar 2008
Først indsendt, der opfyldte QC-kriterier
30. januar 2008
Først opslået (Skøn)
31. januar 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
6. august 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. august 2012
Sidst verificeret
1. august 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RETRIEVE I
- G070035
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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