EndurAnt Vascular Prosthesis System vs. ExcluDer Endoprosthesis: a global, prospective, randomized clinical trial for aneurysm sac regression (ADVANCE trial)
Zusammenfassung der Studie
In the presence of aortic disease, the aortic wall may weaken, causing the diameter of the aorta to increase due to the pressure of the blood flowing through it, leading to a balloon-like dilation. An abdominal aortic aneurysm (AAA) is a bulge in your abdominal aorta (a part of the main artery in the abdominal area). The larger this bulge in your aorta becomes, the more likely it is to rupture. One treatment option for an AAA is endovascular aneurysm repair. The endovascular treatment (through the blood vessel) of aneurysms is a minimally invasive surgical procedure to prevent an aneurysm from growing, and it involves the insertion of an expandable vascular prosthesis (a tubular structure made of a special material, supported by a stable but flexible frame, usually made of metal) into the aorta, without opening the abdominal cavity and operating directly on the aorta. Patients for whom endovascular aneurysm repair is to be performed due to their AAAs may participate in this trial under certain conditions. If a patient is eligible to participate, they will receive either a Medtronic Endurant II/IIs Vascular Prosthesis System or a Gore Excluder/Excluder Conformable AAA Endoprosthesis. The patient will be assigned to one of the two study groups (randomized). One group receives the Medtronic vascular prosthesis system and the other the Gore AAA endoprosthesis. Randomization means that a computer randomly assigns the patient to a group. Neither the patient nor the doctors can decide which group the patient will be in. For this trial, data/information from the treatment routine will be collected. Additionally, CTs/MRIs of the aorta and the product will be performed annually up to 5 years after the procedure.
(BASEC)
Untersuchte Intervention
The purpose of this trial is to obtain clinical evidence for the essential performance outcomes of the Endurant II/IIs Stent Graft System compared to the Gore Excluder/Excluder Conformable AAA Endoprosthesis in patients with abdominal aortic aneurysms.
Approximately 550 patients (at least 500) will be enrolled at up to 100 study centers worldwide, with the possibility of expanding enrollment to up to 900 patients.
Data will be collected from patients at the following time points for the trial:
- Baseline
- Endovascular aneurysm repair
- Discharge
- 1 month after endovascular aneurysm repair
- annually after 1, 2, 3, 4, and 5 years after endovascular aneurysm repair
For this trial, data/information from the treatment routine will be collected. CTs/MRIs of the aorta and the product will be performed at baseline, one month after the procedure, and annually up to 5 years after the procedure.
(BASEC)
Untersuchte Krankheit(en)
Patient with an infrarenal abdominal aortic or aortoiliac aneurysm (AAA) suitable for endovascular abdominal aneurysm repair (EVAR). The products used in this trial are CE marked and approved for public use in patients with abdominal aortic or aortoiliac aneurysms. The products are used in accordance with the authorization in Switzerland. Product names: - Medtronic Endurant II/IIs Vascular Prosthesis System - Gore Excluder/Excluder Conformable AAA Endoprosthesis
(BASEC)
1) The patient is ≥20 years old. 2) The patient and the treating physician agree that the study participant will attend all required follow-up visits. 3) The patient or their legal representative or guardian has consented to participate in the study and has signed the consent form approved by the sponsor and the ethics committee/institutional review board. 4) The patient has an aneurysm diameter of o ≥5 cm (for women) o ≥5.5 cm (for men) 5) The patient's AAA anatomy is deemed suitable for both the Medtronic Endurant II/IIs Vascular Prosthesis System and the Gore Excluder/Excluder Conformable AAA Endoprosthesis, according to the assessment of the treating physician and the central laboratory in accordance with the overlapping commercially available IFUs for the respective region. (BASEC)
Ausschlusskriterien
1) The patient is participating in a drug or product study that could distort or affect the endpoints and follow-up of this trial. 2) The patient has an estimated life expectancy of ≤3 years, according to the investigator's assessment. 3) The patient has an aneurysm with the following characteristics: a) Suprarenal/Pararenal/Juxtarenal b) Isolated ilio-femoral c) Mycotic d) Inflammatory e) Pseudoaneurysm f) Simultaneous or previous dissection of the abdominal aorta or pelvic arteries g) Ruptured h) Symptomatic AAA 4) The patient has significant thrombus and/or calcium at the arterial implantation sites, particularly at the interface between the proximal aortic neck and the distal iliac artery. A significant thrombus can be quantified as a thrombus with a thickness of ≥2 mm and/or ≥25% of the vessel circumference in the intended closure zone of the aortic neck. 5) The patient requires aneurysm emergency treatment, e.g., in case of trauma or rupture. 6) Patients with a connective tissue disease that may have caused the aneurysm, e.g., Marfan syndrome, Ehlers-Danlos, Loeys-Dietz syndrome 7) The patient has previously undergone surgical or endovascular treatment in the abdominal aorta or pelvic artery due to an aneurysm or occlusive disease. 8) Planned use of an aorto-uni-iliac (AUI) main body device 9) Any planned additional device (other than the main body, the leg vascular prosthesis, and the extensions for the randomized treatment) during the index or staged procedure (e.g., endoclip or anchor, endoprosthesis for the iliac arms, embolization, etc.) 10) Planned coverage of the internal iliac artery/arteries 11) The patient has an estimated glomerular filtration rate (eGFR) <45 ml/min/1.73 m2 or the patient is on dialysis. 12) The patient has a systemic infection that, in the investigator's judgment, poses an increased risk for infection of the endovascular graft. 13) The patient has a psychiatric or other condition that, in the investigator's judgment, could affect the trial. 14) The patient is of childbearing age, and pregnancy cannot be ruled out. 15) The patient has a known hypersensitivity to anticoagulants, antiplatelet agents, or contrast agents, or has corresponding contraindications that cannot be eliminated by pre-treatment. 16) The patient belongs to a vulnerable population group, in the investigator's judgment. 17) The patient has an active COVID-19 infection or a relevant history regarding COVID-19. (BASEC)
Studienstandort
Lausanne, Luzern
(BASEC)
Sponsor
Medtronic Schweiz AG
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
PD Dr. med. Sébastien Déglise
+41 21 314 2480
sebastien.deglise@clutterchuv.chCentre hospitalier universitaire vaudois
(BASEC)
Allgemeine Auskünfte
Beth Israel Deaconess Medical Center, United States,Erasmus University Medical Center, Netherlands,
763-514-4000
rs.advancestudy@medtronic.com(ICTRP)
Allgemeine Auskünfte
Beth Israel Deaconess Medical Center, United StatesErasmus University Medical Center, Netherlands
763-514-4000
rs.advancestudy@medtronic.com(ICTRP)
Wissenschaftliche Auskünfte
Beth Israel Deaconess Medical Center, United States,Erasmus University Medical Center, Netherlands,
763-514-4000
rs.advancestudy@medtronic.com(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Waadt
(BASEC)
Datum der Bewilligung durch die Ethikkommission
17.01.2023
(BASEC)
ICTRP Studien-ID
NCT05378347 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
EndurAnt Stent Graft system vs ExcluDer endoprosthesis: a global, prospectiVe, rANdomized Clinical trial in sac rEgression (ADVANCE Trial) (BASEC)
Wissenschaftlicher Titel
Endurant Stent Graft System vs Excluder Endoprothesis: A Global, Prospective, Randomized Clinical Trial in Sac Regression (ICTRP)
Öffentlicher Titel
Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial (ICTRP)
Untersuchte Krankheit(en)
Abdominal Aortic AneurysmAbdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder)Abdominal Aortic Aneurysm >= 5.0 Centimeters in Female (Disorder) (ICTRP)
Untersuchte Intervention
Device: Medtronic Endurant II or Endurant IIs Stent Graft SystemDevice: Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 estimated life expectancy of = 3 years as judged by the investigator
- Subject has an aneurysm that is:
1. Suprarenal/pararenal/juxtarenal
2. Isolated ilio-femoral
3. Mycotic
4. Inflammatory
5. Pseudoaneurysm
6. Concomitant or prior dissection involving the abdominal aorta or iliac arteries
7. Ruptured
8. Symptomatic AAA
- 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 requires emergent aneurysm treatment, for example, trauma or rupture
- Subject with connective tissue disease that may have caused the aneurysm e.g. Marfan
syndrome, Ehlers-Danlos, Loeys-Dietz syndrome
- Subject has previously undergone surgical or endovascular treatment in the abdominal
aorta or the iliac arteries for aneurysm or occlusive disease
- 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 has an estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73m2 or
subject is on dialysis
- 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 is of childbearing potential in whom pregnancy cannot be excluded
- Subject has a known hypersensitivity or contraindication to anticoagulants,
anti-platelets, or contrast media, which is not amenable to pre-treatment
- Subject belongs to a vulnerable population per investigator's judgment
- Subject has an active COVID-19 infection or relevant history of COVID- 19 (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Sac Regression (ICTRP)
Aneurysm sac change by diameter as a continuous variable;Aneurysm sac change by volume incidence rate;Type II endoleak incidence rate;Type I endoleak incidence rate;Secondary intervention incidence rate;All cause mortality incidence rate (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Marc Schermerhorn, MD;Hence Verhagen, MD;ADVANCE Trial Clinical Study Team, rs.advancestudy@medtronic.com, 763-514-4000, Beth Israel Deaconess Medical Center, United States,Erasmus University Medical Center, Netherlands, (ICTRP)
Sekundäre IDs
MDT21033 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT05378347 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar