Type B Aortic Dissection Clinical Trial
Official title:
Aortic Remodeling After Endovascular Management of Type B Aortic Dissection.
Assess the clinical outcome, morphological changes and behaviour of type B aortic dissection after endovascular repair.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | April 1, 2026 |
Est. primary completion date | March 1, 2026 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: 1. Complicated Stanford type B dissections: - Rupture. - malperfusion (visceral, extremities or spinal cord ischemia). 2. High-risk aortic dissections: - Refractory pain, refractory hypertension or bloody pleural effusion. - High-risk radiographic features (max. aortic diameter >40mm, false lumen diameter >22mm, 1ry entry tear >1cm, entry tear location on the lesser curve and radiographic only malperfusin). 3. Aortic anatomy suitable for stent graft therapy: - Proximal landing zone (diameters between 15 and 42mm, measured form outer wall to outer wall) isn't aneurysmal, dissected or significantly thrombosed. - Proximal landing zone length =20mm. - Radius of curvature =20mm for aortic arch landing zones. - Arch or distal aortic angulation 45= degrees. 4. Compatible Iliac and/or femoral access vessel morphology (diameter and tortousity) that allows endovascular access to the dissection site with the delivery system of the appropriately sized device, with or without the use of either surigcal or endovascular conduit. 5. Age =18yrs. 6. Life expectancy >2yrs Exclusion Criteria: 1. Known hypersensitivity to device component or contraindication to anticoagulation or contrast media. 2. Systemic or local infection that may increase the risk of endovascular graft infection. 3. Subjects with past descending or abdominal aortic interventions. 4. Un-correctable coagulopathy 5. Active vasculitis 6. Inability or refusal to give informed consent by subject or legal representative 7. Subject is unwilling to comply with the follow-up schedule. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Medicine | Asyut |
Lead Sponsor | Collaborator |
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Assiut University |
Egypt,
Hagedorn MN, Meisenbacher K, Skrypnik D, Bischoff MS, Bockler D. Standing the test of time: total aortic remodeling 13 years after TEVAR for acute type B aortic dissection. Indian J Thorac Cardiovasc Surg. 2024 Jan;40(1):86-90. doi: 10.1007/s12055-023-01586-5. Epub 2023 Sep 4. — View Citation
Iannuzzi JC, Stapleton SM, Bababekov YJ, Chang D, Lancaster RT, Conrad MF, Cambria RP, Patel VI. Favorable impact of thoracic endovascular aortic repair on survival of patients with acute uncomplicated type B aortic dissection. J Vasc Surg. 2018 Dec;68(6):1649-1655. doi: 10.1016/j.jvs.2018.04.034. Epub 2018 Jun 15. — View Citation
Jiang X, Liu Y, Zou L, Chen B, Jiang J, Fu W, Dong Z. Long-Term Outcomes of Chronic Type B Aortic Dissection Treated by Thoracic Endovascular Aortic Repair. J Am Heart Assoc. 2023 Jan 3;12(1):e026914. doi: 10.1161/JAHA.122.026914. Epub 2022 Nov 16. — View Citation
Lombardi JV, Cambria RP, Nienaber CA, Chiesa R, Mossop P, Haulon S, Zhou Q, Jia F; STABLE investigators. Aortic remodeling after endovascular treatment of complicated type B aortic dissection with the use of a composite device design. J Vasc Surg. 2014 Jun;59(6):1544-54. doi: 10.1016/j.jvs.2013.12.038. Epub 2014 Feb 19. — View Citation
Lombardi JV, Hughes GC, Appoo JJ, Bavaria JE, Beck AW, Cambria RP, Charlton-Ouw K, Eslami MH, Kim KM, Leshnower BG, Maldonado T, Reece TB, Wang GJ. Society for Vascular Surgery (SVS) and Society of Thoracic Surgeons (STS) Reporting Standards for Type B Aortic Dissections. Ann Thorac Surg. 2020 Mar;109(3):959-981. doi: 10.1016/j.athoracsur.2019.10.005. Epub 2020 Jan 27. — View Citation
Riambau V, Bockler D, Brunkwall J, Cao P, Chiesa R, Coppi G, Czerny M, Fraedrich G, Haulon S, Jacobs MJ, Lachat ML, Moll FL, Setacci C, Taylor PR, Thompson M, Trimarchi S, Verhagen HJ, Verhoeven EL, Esvs Guidelines Committee, Kolh P, de Borst GJ, Chakfe N, Debus ES, Hinchliffe RJ, Kakkos S, Koncar I, Lindholt JS, Vega de Ceniga M, Vermassen F, Verzini F, Document Reviewers, Kolh P, Black JH 3rd, Busund R, Bjorck M, Dake M, Dick F, Eggebrecht H, Evangelista A, Grabenwoger M, Milner R, Naylor AR, Ricco JB, Rousseau H, Schmidli J. Editor's Choice - Management of Descending Thoracic Aorta Diseases: Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2017 Jan;53(1):4-52. doi: 10.1016/j.ejvs.2016.06.005. No abstract available. — View Citation
Rodriguez JA, Olsen DM, Lucas L, Wheatley G, Ramaiah V, Diethrich EB. Aortic remodeling after endografting of thoracoabdominal aortic dissection. J Vasc Surg. 2008 Jun;47(6):1188-94. doi: 10.1016/j.jvs.2008.01.022. Epub 2008 Apr 28. — View Citation
Sobocinski J, Lombardi JV, Dias NV, Berger L, Zhou Q, Jia F, Resch T, Haulon S. Volume analysis of true and false lumens in acute complicated type B aortic dissections after thoracic endovascular aortic repair with stent grafts alone or with a composite device design. J Vasc Surg. 2016 May;63(5):1216-24. doi: 10.1016/j.jvs.2015.11.037. Epub 2016 Jan 22. — View Citation
Trimarchi S, Gleason TG, Brinster DR, Bismuth J, Bossone E, Sundt TM, Montgomery DG, Pai CW, Bissacco D, de Beaufort HWL, Bavaria JE, Mussa F, Bekeredjian R, Schermerhorn M, Pacini D, Myrmel T, Ouzounian M, Korach A, Chen EP, Coselli JS, Eagle KA, Patel HJ. Editor's Choice - Trends in Management and Outcomes of Type B Aortic Dissection: A Report From the International Registry of Aortic Dissection. Eur J Vasc Endovasc Surg. 2023 Dec;66(6):775-782. doi: 10.1016/j.ejvs.2023.05.015. Epub 2023 May 16. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Analysis of aortic remodeling | evaluation of diameter changes between the preoperative and postoperative CTs measurements in millimetres . The true lumen index (Tli) is calcuated by dividing thr true lumen diameter by the whole lumen (transaortic) diameter. The fasle lumen index (Fli) is calculated in the same manner. The desirable TLi value approaches or equals 1 (suggesting increase in true lumen to normal), whereas the sought-after FLi value approaches or equals 0 (suggesting shrinkage in false lumen). | 2 years | |
Primary | technical success | successful delivery and deployment of the device with coverage of the 1ry tear at implant with no detected endoleak on angiography | baseline |
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