- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03322033
Feasibility of Endovascular Repair of Ascending Aortic Pathologies (PS-IDE)
Proposed Single Center Investigational Device Exemption: Feasibility of Endovascular Repair of Ascending Aortic Pathologies
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The purpose of this early feasibility study is to investigate the outcome of selected patients with ascending aortic pathologies including type A aortic dissection, retrograde type A aortic dissection, who are suitable for endovascular repair with the Valiant PS-IDE Stent Graft device. The investigators propose to study patients with Dissections affecting the aorta between the Sinus of Valsalva and the innominate artery orifice (with no involvement of aortic valve). In these patients, the ascending aorta will be repaired using the stent graft. For patients with type A aortic dissection, the investigators expect to reroute the blood to the true lumen by covering the proximal tear. In patients with retrograde type A aortic dissection, there might or might not be additional tears in the ascending aorta. If they are tears in ascending aorta, these dissections behave similarly like a type A aortic dissection, in which all the tears in the ascending aorta need to be covered. If the proximal tear is only in the descending thoracic aorta, these patients will require coverage in the ascending aorta with the stent graft along with coverage of proximal tear in the descending thoracic aorta using Valiant stent graft.
Patients will be selected from a high-risk surgical cohort. The total number of enrolled subjects is planned to be 20.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Megan C White, BA
- Telefonnummer: 469-814-4720
- E-post: megan.white1@bswhealth.org
Studiesteder
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Texas
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Plano, Texas, Forente stater, 75035
- Rekruttering
- Baylor Scott & White The Heart Hospital
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Ta kontakt med:
- Pauline Matheri
- E-post: pauline.matheri@bswhealth.org
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Ta kontakt med:
- Megan White
- E-post: megan.white1@bswhealth.org
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
In order to qualify for this physician-sponsored Investigational Device Exemption, the patients would have to meet the entire entry criteria listed below, sign a consent approved by the FDA and IRB, and agrees to follow-up according to the study protocol.
Patient must have a type A thoracic aortic dissection, retrograde type A thoracic aortic dissection of the ascending thoracic aorta affecting the area between the Sinus of Valsalva and the innominate artery orifice (with no involvement of the aortic valve) and be considered a candidate for endovascular repair;
- The proximal and distal landing zones for placement of graft should be at least 1 cm.
- The proximal landing zone will allow placement of the stent graft as to not inhibit valvular function, occlude a coronary ostium or proximal bypass graft; The aortic root may be dissected, but the proximal tear site must be at least 1cm from the STJ (and within the above listed size criteria).
- Distal landing zone must allow for continued perfusion of critical cerebral vessels;
- The aorta as measured adventitial wall to adventitial wall must be greater than 28 mm and no more than 44 mm maximum diameter at both the proximal and distal landing zone.
- The patient must be high-risk surgical candidate according to the following established criteria: ASA score of IV.
Exclusion Criteria:
- Pregnant or pediatric patients (younger than 21 years of age);
- Patients who have a condition that threatens to infect the stent graft/aortic valve prosthesis;
- Patients with allergies to the stent graft material;
- Patients or their legally authorized representative (LAR) who do not sign the informed consent;
- Patients with expected survival less than one year due to a condition other than the ascending aortic
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Type A Dissection
High risk subjects with ascending thoracic aortic pathologies including type A aortic dissection who are suitable for endovascular repair
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Medtronic Valiant PS-IDE Stent Graft System with the Captivia Delivery System
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Freedom from early death
Tidsramme: 30 days
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Freedom from early death at 30-days post-procedure
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30 days
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: William Brinkman, MD, Cardiac Surgery Specialists
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
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
Andre studie-ID-numre
- G170196
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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