- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00802984
Endovascular Repair of Descending Thoracic Aortic Aneurysms
5. oktober 2020 opdateret af: Stanford University
Endovascular Treatment of Thoracic Aortic Aneurysms Using the TALENT Stent Graft System
The purpose of this study is to determine whether the system is safe and effective for the intended use of treating descending thoracic aortic aneurysms.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
29
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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California
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Stanford, California, Forenede Stater, 94305
- Stanford University School of Medicine
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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:
- Patient is a candidate for repair of a descending thoracic aortic aneurysm.
Patient has one or more of the following:
- Descending thoracic aneurysm, 5 cm in diameter or greater with proximal and distal neck suitable for stent graft placement.
- Aneurysm is 4-5 cm in diameter but has increased in size by 0.5 cm in last 6 months.
- Maximum diameter of aneurysm exceeds one and one-half times the transverse dimension of an adjacent normal aortic segment.
- Post-traumatic pseudoaneurysm
- Post-surgical pseudoaneurysm
- Saccular aneurysm
- Contained rupture
- Penetrating ulcer
- Patient's vascular dimensions must be in the range that can be safely treated with the stent graft and extensions available to the physician at the time of the procedure.
- Patient has patent iliac or femoral arteries or acceptable retroperitoneal access via the abdominal aorta that allow endovascular access to the aneurysmal site with a 23F delivery catheter, typically used with a 25F introducer sheath
- Patient has a non-aneurysmal proximal and distal aortic neck diameter between 25 and 36 mm.
- Patient is American Society of Anesthesiology (ASA) grade 1 through 4.
- Patient has a stage of disease or condition where there is no comparable or satisfactory alternative device or therapy available for treatment; or the patient has an immediately life-threatening disease in which there is a reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment.
- Patient is able and willing to comply with 1 month, 6 month, and 1 year follow-up, and willing to comply with annual post-treatment follow-up requirements thereafter.
- Patient or patient's legal representative understands and has signed an Informed Consent.
Exclusion Criteria:
- The stent graft would have to be positioned such that there would be no flow to an artery, major branch artery or major branch arteries which supply the spinal cord.
- The patient has congenital abnormalities in which the placement of the stent graft will cause occlusion of major arterial flow. Such abnormalities should be evaluated prior to treatment.
- Patient is pregnant.
- Patient is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta.
- Patient has connective tissue disease.
- Patient has a hypercoagulability disorder.
- Patient is in acute renal failure.
- Patient has active systemic infection.
- Patient is less than 18 years old.
- Patient has less than a one-year life expectancy.
- Patient is participating in another research study involving an investigational agent for the treatment of Descending Thoracic Aortic Aneurysms.
- Patient has other medical, social or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.
- Patient is unwilling or unable to return for or comply with follow-up visit schedules.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Stent graft migration
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Aneurysm exclusion
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Stent graft occlusion
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Collateral vessel occlusion
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Aneurysm rupture
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Vessel Dissection or perforation
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Sekundære resultatmål
Resultatmål |
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Teknisk succes
|
Patency
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Christopher K Zarins, MD, Stanford University
- Jason T Lee, MD
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 (Faktiske)
1. januar 2002
Primær færdiggørelse (Faktiske)
1. december 2005
Studieafslutning (Faktiske)
1. december 2005
Datoer for studieregistrering
Først indsendt
4. december 2007
Først indsendt, der opfyldte QC-kriterier
4. december 2008
Først opslået (Skøn)
5. december 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. oktober 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. oktober 2020
Sidst verificeret
1. oktober 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SU-11092007-868
- IRB Protocol Number 77836
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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