Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

A vizsgálat adatai

Ki végzi

Baptist Health South Florida

Azonosító

NCT01524211

A regiszteradat frissítve

2026. június 15.

Eredeti leírás

Zenith t-Branch Study Cohort: The purpose of this study is to collect information on the Cook Zenith t-Branch endovascular stent-graft system and the Terumo Arch Branch for the treatment of aortic aneurysms.A teljes eredeti leírásKevesebb

Zenith t-Branch Study Cohort: The purpose of this study is to collect information on the Cook Zenith t-Branch endovascular stent-graft system and the Terumo Arch Branch for the treatment of aortic aneurysms.

Terumo Arch Branch Study Cohort: The purpose of this additional study arm to the current IDE clinical trial is to collect a priori information on the Terumo Arch Branch Endograft for the treatment of proximal thoracic aortic pathologies that cannot be treated with conventional thoracic endografts.

Bevonási feltételek: The patient must have one of the following:; Degenerative, atherosclerotic thoracoabdominal, suprarenal and juxtarenal aortic aneurysms (fusiform or saccular):≥55mm in diameter in a male or ≥50mm in diameter in a female, or; Thoracoabdominal aortic aneurysm with a history of growth ≥0.5 cm per year, or; Penetrating ulcers: ≥20mm in depth or; Chronic type B aortic dissections: ≥50mm total aortic diameter or; Symptomatic pathology (aneurysm, ulcer or chronic dissection) of any size; Additional criteria for LP material; Iliofemoral access vessels <8mm or with significant atherosclerotic occlusive disease that would require an iliac conduit as determined by the Principle Investigator; The subject must have one of the following:; Degenerative, atherosclerotic aneurysm involving the ascending aorta, aortic arch or proximal descending aorta ≥55 mm in diameter or > 50 mm with a history of growth ≥5 mm in the last 6 months, or; Penetrating ulcers: ≥20 mm in depth, or; Chronic aortic dissections: ≥50mm total aortic diameter. AND Prohibitive or high-risk for standard open surgical repair, defined as having one or more of the following pre-existing conditions; Age >85 years old; Prior median sternotomy (for any reason); Prior open or endovascular thoracic aortic repair; Severe aortic calcification; Severe occlusive disease of one or more arch vessels; Moderate-severe COPD (FEV1 <80% predicted); Severe CKD (Stage 3 or greater, eGFR <60 mL/min); LV dysfunction; Chronic steroid or immunosuppressive use; History of increased risk of bleeding; Neurocognitive deficits that may significantly impact postoperative rehabilitation; Musculoskeletal conditions that may significantly impact postoperative rehabilitation.

Kizáró feltételek: Prior mechanical aortic valve replacement (not bioprosthetic); Uncontrolled systemic infection; Untreatable malignancy; Known allergy(ies) to device materials; Anatomic Criteria; Pending cardiac surgery; Untreatable severe, symptomatic coronary or valvular disease; History of TAVR (Transcatheter Aortic Valve Replacement); Uncontrolled systemic infection; Untreatable malignancy with <1 year expected survival; Known allergy(ies) to device materials. (i.e. polyester, nitinol); Anatomic Criteria; Age <18 years; Age <18 years; General Criteria; Life-expectancy less than 12 months; Refusal to receive blood products; Pregnant or breastfeeding or planning on becoming pregnant within 60 months; Unwilling to comply with the follow-up schedule; Inability or refusal to give informed consent by subject and/or Legally Authorized Representative (LAR); should one be utilized; Medical Criteria; Uncontrollable anaphylaxis to iodinated contrast; Any pathology of mycotic origin; Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial); Inability to insert the Zenith® t-Branch device through iliofemoral approach; Proximal and distal neck angle less than 90 degrees relative to the long axis of the aneurysm; Proximal landing zone length <25mm to allow secure fixation and seal; Proximal landing zone diameter of <24mm or >42mm; Distal landing zone length <25mm in the abdominal aorta or <20mm in the iliac arteries; Distal landing zone diameter of <14mm or >30mm in the abdominal aorta, or <7mm or >28mm in the iliac arteries; Terumo Arch Branch Eligibility Criteria; General Criteria; Life expectancy <1 year; Refusal to receive blood products; Pregnant, breastfeeding, or planning to become pregnant within 60 months; Unwilling to comply with the follow-up schedule; Inability or refusal to give informed consent by subject and/or Legally Authorized Representative (LAR); should one be utilized; Willingness to travel, if needed, to participate in a manufacturer-sponsored clinical trial at another institution; Medical Criteria; Severe, calcific aortic valvular stenosis; Uncontrollable anaphylaxis to iodinated contrast; Any pathology of mycotic origin; Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial); Acute (<2 weeks) aortic dissection; Type A dissection; Symptomatic or ruptured pathology; Anatomy suitable for repair using commercially-available endograft; Inability to insert the Arch Branch endograft through an iliofemoral approach; Untreated, known extracranial carotid stenosis >80%; Ascending aortic angulation with radius of curvature <15mm in the intended landing zone; Proximal aortic landing zone length <25 mm; Proximal aortic landing zone diameter of >43mm or <28 mm; Distal aortic landing zone diameter <20 mm; Total length along the outer curve from the distal coronary to the proximal edge of the brachiocephalic trunk <70mm; Target arch vessels:; Distal branch landing zone dimensions: I. Brachiocephalic trunk (innominate artery, BCT): Diameter >24 mm or <6 mm, length <15 mm. ii. Common carotid artery: Diameter <6 mm, length <25mm. iii. Subclavian artery: Diameter <6 mm, length <25mm.

Zenith t-Branch Eligibility Criteria:.

ClinicalTrials.gov NCT01524211