MBA Early Feasibility Study

A vizsgálat adatai

Ki végzi

W.L.Gore & Associates

Azonosító

NCT07564375

A regiszteradat frissítve

2026. október 1.

Eredeti leírás

The MBA 25-04 study is a prospective, multicenter, non-randomized, single-arm, early feasibility study designed to assess the initial safety of the MBA device through five years following the index endovascular procedure.A teljes eredeti leírásKevesebb

Early Feasibility Study of the GORE® Multibranch Arch Endoprosthesis (MBA Device)

The MBA 25-04 study is a prospective, multicenter, non-randomized, single-arm, early feasibility study designed to assess the initial safety of the MBA device through five years following the index endovascular procedure.

Bevonási feltételek: The subject is / has:; Thoracic pathologies with involvement of the arch branch vessels, that are compatible with the treatment requirements of the MBA device, and meeting any of the following criteria:; Aneurysm and Isolated Lesions: i. Fusiform aneurysm (≥ 55 mm or documented growth rate > 0.5 cm/year). ii. Saccular aneurysm (no diameter criteria). iii. Pseudoaneurysms (> 30 days post-surgery, no diameter criteria). iv. Penetrating Aortic Ulcers (PAUs) without intramural hematoma (IMH) (no diameter criteria); Aortic dissection: i. Uncomplicated and high-risk chronic de novo (> 90 days) Type B aortic dissection with primary entry tear in the arch or descending thoracic aorta; Residual aortic dissection following surgical repair of Type A aortic dissection requiring treatment (> 30 days post-treatment); Proximal extension of prior endovascular repair (> 30 days post-treatment and > 90 days post-dissection) of a Type B dissection requiring treatment; Pseudoaneurysms, following open surgical repair of a Type A dissection (> 30 days post-surgery, no diameter criteria); Anatomic compatibility with MBA device and other devices required for proximal or distal extensions based on Gore's review; Adequate vascular access via transfemoral or retroperitoneal approach; Appropriate vascular access to allow for through-wire access to the brachiocephalic artery, LCCA, and LSA; Proximal Aortic Landing Zone:; Landing zone is native aorta, surgical graft, or previously implanted GORE thoracic stent graft; Landing zone diameter between 27 mm - 48 mm. iii. Acceptable ascending aorta outer curvature length for the required MBA device; Proximal segment length (length from distal edge of brachiocephalic artery to distal edge of the most distal coronary artery) must be ≥ 2 cm longer than the "AC Proximal End to BCA Portal Length" for the selected Aortic Component or ≥ 3 cm if the landing zone is > 42 mm; For patients with patent bypass graft from the ascending aorta, proximal extent of landing zone must be ≥ 1 cm distal to the bypass graft; Lesion location is ≥ 2 cm distal to the most distal coronary artery ostium. v. For patients with an existing transcatheter aortic valve replacement (TAVR) there must be a sufficient proximal landing zone to avoid interference with the required MBA device (including any proximal extensions with the ASG device); Proximal landing zone must be ≥ 2 cm in the ascending aorta; For patients with prior replacement of the ascending aorta and / or aortic arch by surgical graft, there must be ≥ 2 cm overlap of MBA device and previously implanted graft; For patients with a de novo aortic dissection, the primary entry tear must be located ≥ 2 cm distal to the proximal extent of the MBA device (including any proximal extensions) and the proximal edge of the stent graft must land in non-dissected aorta; Landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed; Branch Vessel Landing Zone: i. Length of ≥ 2.5 cm proximal to first major branch vessel. ii. Target branch vessel inner diameter of 11-18 mm for the 12 mm portal, and 6-15 mm for the 8 mm portal; Target branch vessel landing zone must be in native aorta that cannot be heavily calcified, or heavily thrombosed; All three arch target vessels must have appropriate anatomy for cannulation (including through-wire access) and treatment with MBA branch components; Distal Aortic Landing Zone (aneurysms and isolated lesions only): i. Outer curvature length must be ≥ 2 cm proximal to the celiac artery. ii. Aortic inner diameters between 16-42 mm. iii. Landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed; Landing zone in native aorta, surgical graft, or previously implanted GORE thoracic stent graft; Age ≥ 18 years at time of informed consent signature; Informed Consent Form (ICF) signed by the subject or legally authorized representative (LAR), according to local regulation; Agrees to comply with protocol requirements, including imaging and five year (60 month) follow-up; Considered high-risk for open surgical repair by meeting one or more of the following criteria:; ≥ 75 years of age; Previous median sternotomy; Documented identification of other subject-specific risk factors (e.g., medical history, active medical diagnosis) by a study investigator and an experienced open ascending and / or aortic arch surgeon (e.g., cardiothoracic surgeon); Considered high-risk for surgical debranching by meeting one or more of the following criteria:; Prior neck surgery or radiation; Neck anatomy / body habitus impeding carotid access or safe bypass tunneling; Dysphagia; Elevated risk for post-operative infection (e.g., malnutrition, uncontrolled diabetes (hemoglobin A1c > 9%), current treatment with immunosuppressant therapy or chemotherapy); Reduced pulmonary function (e.g., severe chronic obstructive pulmonary disease (COPD), current or anticipated tracheostomy); Clinical Frailty Scale score 6-7; Documented identification of other subject-specific risk factors which would pose high risk for surgical debranching (e.g., medical history, active medical diagnosis) by a study investigator.

Kizáró feltételek: Any aortic valve repair or replacement including transcatheter aortic valve replacement (TAVR) or coronary artery intervention within 30 days prior to treatment; Complex percutaneous coronary intervention (PCI) within 30 days prior to treatment; Open chest surgical repair within 30 days prior to treatment; Any open or interventional repair of either carotid artery within 30 days prior to treatment; Previous endovascular repair with a non-Gore device that would interfere with or result in contact with planned repair; Concomitant vascular disease, including disease associated with the great and upper extremity vessels, requiring treatment that is not planned for index endovascular procedure; Any stroke or MI within 90 days prior to treatment; Participation in investigational drug or medical device study within one year of enrollment unless approved by the sponsor; Active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication); Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin or a history of a hypercoagulability disorder and / or state; Prosthetic heart valve in the aortic position that precludes safe delivery of any study device; Aortic insufficiency (AI) grade 3 or greater; Presence of protruding and / or irregular thrombus and / or atheroma in the ascending aorta or aortic arch or any other factor that could increase the risk of stroke based on Gore's review; Any chronic condition that is not well controlled and that is known to increase stroke risk; Known degenerative connective tissue disease (e.g., Marfan's or Ehler-Danlos Syndrome (EDS)); Known medical, social, or psychological issues that the Investigator believes may interfere with treatment or follow-up, such as a history of drug abuse within one year of treatment; Active infected aorta, mycotic aneurysm; Known sensitivities or allergies to the device materials; Known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment; Body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta; Severe Congestive Heart Failure (CHF) (New York Heart Association (NYHA) functional class IV); Acute Coronary Syndrome (ACS) including unstable angina; Renal failure, defined as patients with an estimated Glomerular Filtration Rate (eGFR) < 30 (mL/min/1.73 m2) or currently requiring dialysis; The subject is / has:; De novo Type A dissection; Requires immediate treatment; Arch vessels with dissection extending into the intended landing zones; Anticipated need for coronary or aortic valve intervention within one year post-treatment; Presence of Intramural Hematoma (IMH) in landing zones; Pregnant at time of procedure or planning to become pregnant within the first 12-months of participation in the study; Life expectancy <12 months.

ClinicalTrials.gov NCT07564375