Aortic Remodeling After Endovascular Management of Type B Aortic Dissection.

NCT06289777 | Not Yet Recruiting

• 1 other identifier: aortic remodeling
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Assess the clinical outcome, morphological changes and behaviour of type B aortic dissection after endovascular repair.

Conditions

Type B Aortic Dissection

Outcome Measures

Primary Outcomes (2)

• 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

• technical success

  successful delivery and deployment of the device with coverage of the 1ry tear at implant with no detected endoleak on angiography

  baseline

Interventions

TEVAR PROCEDURE

minimally invasive endovascular intervention to treat aortic dissection

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

complicated or high-risk acute, subacute or chronic type B aortic dissection.

You may qualify if:

• Complicated Stanford type B dissections:
• Rupture.
• malperfusion (visceral, extremities or spinal cord ischemia).
• 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).
• 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.
• 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.
• Age ≥18yrs.
• Life expectancy \>2yrs

You may not qualify if:

• Known hypersensitivity to device component or contraindication to anticoagulation or contrast media.
• Systemic or local infection that may increase the risk of endovascular graft infection.
• Subjects with past descending or abdominal aortic interventions.
• Un-correctable coagulopathy
• Active vasculitis
• Inability or refusal to give informed consent by subject or legal representative
• Subject is unwilling to comply with the follow-up schedule.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine

Asyut, 71515, Egypt

Location

Related Publications (10)

• Watanabe Y, Shimamura K, Yoshida T, Daimon T, Shirakawa Y, Torikai K, Sakamoto T, Shijo T, Toda K, Kuratani T, Sawa Y. Aortic remodeling as a prognostic factor for late aortic events after thoracic endovascular aortic repair in type B aortic dissection with patent false lumen. J Endovasc Ther. 2014 Aug;21(4):517-25. doi: 10.1583/13-4646R.1.

  PMID: 25101579 BACKGROUND

• 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.

  PMID: 38125333 BACKGROUND

• 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.

  PMID: 18440180 BACKGROUND

• 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.

  PMID: 24560244 BACKGROUND

• 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.

  PMID: 28081802 BACKGROUND

• 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.

  PMID: 29914833 BACKGROUND

• 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.

  PMID: 36382952 BACKGROUND

• 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.

  PMID: 32000979 BACKGROUND

• 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.

  PMID: 26806523 BACKGROUND

• 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.

  PMID: 37201718 BACKGROUND

MeSH Terms

Interventions

Endovascular Aneurysm Repair

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Central Study Contacts

mohamed h elkady, MMed

CONTACT

+201008182199; mohamed.hesham.elkady@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: February 17, 2024
• First Posted: March 4, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 4, 2024

Record last verified: 2024-02

Locations

EG (1)