Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial
A legfontosabb adatok
- Hol
- Albany, Atlanta, Baltimore, Boston, Charlottesville, Cleveland, Denver, Greenville, Houston, Jacksonville, Lexington, Loma Linda, Memphis, Minneapolis, New Haven, New York, Newport Beach, Orange, Philadelphia, Pittsburgh, Plano, Portland, Rochester, Sacramento, San Francisco, Sarasota, Skokie, Springfield, Valhalla, Washington D.C., Wichita és Winston-Salem (Egyesült Államok)Mind a 32 helyszín megnézése
Helyszínek itt: Egyesült Államok
- Albany Medical CollegeAlbany, Egyesült ÁllamokContact: ADVANCE Trial Clinical Study TeamNo longer taking part
- Northside Hospital ForsythAtlanta, Egyesült ÁllamokContact: Siddharth PatelRésztvevőt keres
- VA Maryland Health Care SystemBaltimore, Egyesült ÁllamokContact: Areck Ucuzian, MD (principal investigator)Résztvevőt keres
- Beth Israel Deaconess Medical CenterBoston, Egyesült ÁllamokContact: Marc Schermerhorn, MD (principal investigator)Résztvevőt keres
- University of Virginia Health SystemCharlottesville, Egyesült ÁllamokContact: Margaret C Tracci, MD, JD (principal investigator)Résztvevőt keres
- University Hospitals Cleveland Medical Center*Cleveland, Egyesült ÁllamokContact: Jae Cho, MD (principal investigator)Résztvevőt keres
- Denver Health Medical CenterDenver, Egyesült ÁllamokContact: Lisa Bennett, MD, MS (principal investigator)Résztvevőt keres
- Prisma HealthGreenville, Egyesült ÁllamokContact: ADVANCE Trial Clinical Study TeamNo longer taking part
- University of Texas Health Science Center at HoustonHouston, Egyesült ÁllamokContact: Rana Afifi, MD (principal investigator)Résztvevőt keres
- Mayo Clinic- JacksonvilleJacksonville, Egyesült ÁllamokContact: Young Erben, MD (principal investigator)Résztvevőt keres
- University of KentuckyLexington, Egyesült ÁllamokContact: William Rothstein, MD (principal investigator)Résztvevőt keres
- Loma Linda University Medical CenterLoma Linda, Egyesült ÁllamokContact: Ahmed Abou-Zamzam, MD (principal investigator)Résztvevőt keres
- Cardiovascular Surgery ClinicMemphis, Egyesült ÁllamokContact: ADVANCE Trial Clinical Study TeamNo longer taking part
- Minneapolis Heart Institute FoundationMinneapolis, Egyesült ÁllamokContact: Jeffrey JimRésztvevőt keres
- Yale Center for Clinical InvestigationNew Haven, Egyesült ÁllamokContact: David Kuwayama, MD (principal investigator)Résztvevőt keres
- Northwell Health- Lenox Hill HospitalNew York, Egyesült ÁllamokContact: Alfio Carroccio, MD (principal investigator)Résztvevőt keres
- Hoag HospitalNewport Beach, Egyesült ÁllamokContact: Allen MurgaRésztvevőt keres
- University of California Irvine Medical CenterOrange, Egyesült ÁllamokContact: Anthony Chau, MD (principal investigator)Résztvevőt keres
- Hospital of the University of PennsylvaniaPhiladelphia, Egyesült ÁllamokContact: Grace Wang, MD (principal investigator)Résztvevőt keres
- University of Pittsburgh Medical CenterPittsburgh, Egyesült ÁllamokContact: Nathan Liang, MD (principal investigator)Résztvevőt keres
- The Heart Hospital Baylor PlanoPlano, Egyesült ÁllamokContact: Elyza GuerreroRésztvevőt keres
- Maine Medical CenterPortland, Egyesült ÁllamokContact: Kristina Giles, MD (principal investigator)Résztvevőt keres
- Mayo Clinic - RochesterRochester, Egyesült ÁllamokContact: Randall DeMartino, MD (principal investigator)Résztvevőt keres
- University of California, Davis Medical CenterSacramento, Egyesült ÁllamokContact: ADVANCE Trial Clinical Study TeamNo longer taking part
- University of California San Francisco - UCSF Medical CenterSan Francisco, Egyesült ÁllamokContact: Jade Hiramoto, MD (principal investigator)Résztvevőt keres
- Sarasota Memorial HospitalSarasota, Egyesült ÁllamokContact: Jason Wagner, MD (principal investigator)Résztvevőt keres
- NorthShore University Health SystemSkokie, Egyesült ÁllamokContact: Cheong Jun Lee, MD (principal investigator)Résztvevőt keres
- Baystate Medical CenterSpringfield, Egyesült ÁllamokContact: Matthew Kronick, MD (principal investigator)Résztvevőt keres
- Westchester Medical CenterValhalla, Egyesült ÁllamokContact: Igor Laskowski, MD (principal investigator)Résztvevőt keres
- MedStar Washington Hospital CenterWashington D.C., Egyesült ÁllamokContact: William Yoon, MD (principal investigator)Résztvevőt keres
- Ascension Via Christi Saint FrancisWichita, Egyesült ÁllamokContact: Chad Ammar, MD (principal investigator)Résztvevőt keres
- Novant Health Forsyth Medical CenterWinston-Salem, Egyesült ÁllamokContact: Phillip Moore, MD (principal investigator)Résztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Medtronic Cardiovascular
- Azonosító
- NCT05378347
- A regiszteradat frissítve
- 2026. július 6.
- Eredeti leírás
The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are randomized and imaging collected at all follow-up time points to assess the primary endpoint.A teljes eredeti leírásKevesebb
Endurant Stent Graft System vs Excluder Endoprothesis: A Global, Prospective, Randomized Clinical Trial in Sac Regression
The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are randomized and imaging collected at all follow-up time points to assess the primary endpoint.
Bevonási feltételek: Subject and the treating physician agree that the subject will return for all required follow up visits; Subject or legal representative or consultee, as applicable, has consented for trial participation and signed the Informed Consent approved by the sponsor and by the Ethics Committee/Institutional Review Board; Subject has an aneurysm diameter of ≥ 5 cm (if woman) ≥ 5.5 cm (if man) or as stated otherwise in regional addenda; Subject's AAA anatomy is appropriate for both Medtronic Endurant II/IIs Stent Graft System and Gore Excluder/Excluder Conformable AAA Endoprosthesis as per assessment of both treating physician and Core Lab in accordance with the overlapping commercially available IFUs per applicable region.
Kizáró feltételek: Subject is participating in an investigational drug or device study which may bias or interfere with the endpoints and follow-up of this trial; Subject has an aneurysm that is:; Suprarenal/pararenal/juxtarenal; Isolated ilio-femoral; Mycotic; Inflammatory; Pseudoaneurysm; Concomitant or prior dissection involving the abdominal aorta or iliac arteries; Ruptured; Symptomatic AAA; Subject has previously undergone surgical or endovascular treatment in the abdominal aorta or the iliac arteries for aneurysm or occlusive disease; Subject with connective tissue disease that may have caused the aneurysm e.g. Marfan syndrome, Ehlers-Danlos, Loeys-Dietz syndrome; Subject has a systemic infection who may be at increased risk of endovascular graft infection, per investigator's discretion; Subject has a psychiatric or other condition that may interfere with the trial, per investigator's discretion; Subject has an active COVID-19 infection or relevant history of COVID- 19; Subject has significant thrombus and / or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface. Significant thrombus may be quantified as thrombus ≥ 2 mm in thickness and / or ≥ 25% of the vessel circumference in the intended seal zone of the aortic neck; Subject has an estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73m2 or subject is on dialysis; Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment; Subject has an estimated life expectancy of ≤ 3 years as judged by the investigator; Subject requires emergent aneurysm treatment, for example, trauma or rupture; Planned use of aorto-uni-iliac (AUI) main body device; Any planned additional device (apart from the main body, limb stent graft and extensions per assigned treatment per randomization) during index or staged procedure, e.g., endostaple or anchor, Iliac branch endoprosthesis, embolization, etc; Planned coverage of the internal iliac artery/arteries; Subject is of childbearing potential in whom pregnancy cannot be excluded; Subject belongs to a vulnerable population per investigator's judgment.