Type B Aortic DissectionNCT06289777
Aortic Remodeling After Endovascular Management of Type B Aortic Dissection.
An observational study of Type B Aortic Dissection, run by Assiut University at 1 site in Egypt.
Trial summary
Assess the clinical outcome, morphological changes and behaviour of type B aortic dissection after endovascular repair. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Type B Aortic Dissection
- What is being tested?
- TEVAR
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
Study population: complicated or high-risk acute, subacute or chronic type B aortic dissection.
Who may be able to join
- 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).
Show all 14Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Assess the clinical outcome, morphological changes and behaviour of type B aortic dissection after endovascular repair.
Read the detailed description
Aortic dissection (AD) is considered the most common catastrophic event of the aorta, and its incidence has been reported to be ≈3/100000 per year, exceeding that of ruptured abdominal aortic aneurysm.
AD is a dynamic process and can occur anywhere along the course of the aorta, with the pathognomonic lesion being an intimal tear followed by blood surging either antegrade (typically) or retrograde, cleaving the the intima and medial layers of the aortic wall longitudinally for a variable distance, thus creating a true and false lumens.
Aortic dissections are classified by chronicity, anatomic location of false lumen, generally the entry tear and longitudinal extent, and the presence or absence of complicating features.
Temporally, AD is categorized as acute phase {<14 days}, subacute {15-90 days}, and chronic {>90 days}.
Thoracic Endovascular Aortic Repair (TEVAR) has emerged as the first-line therapy for the treatment of AD, with better short-term results than open repair due to a significant decrease in perioperative morbidity and mortality.
By covering the primary entry tear with stent-grafts, the blood flow is redirected into the true lumen, resolving malperfusion and/or preventing rupture of the false lumen, followed by its regression and re-expansion of the true lumen, which is known as "Aortic remodeling"
- Conditions
- Type B Aortic Dissection
- Being tested
- TEVAR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEVARProcedure or surgery
minimally invasive endovascular intervention to treat aortic dissection
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Type B Aortic DissectionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed hesham abdelrahem husiein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289777
- Sponsor's protocol ID
- aortic remodeling
- Status last verified
- Feb 2024
- First submitted
- 17 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25101579Hagedorn 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.
PubMed 38125333Rodriguez 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.
PubMed 18440180Lombardi 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.
PubMed 24560244Riambau 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.
PubMed 28081802Iannuzzi 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.
PubMed 29914833Jiang 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.
PubMed 36382952Lombardi 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.
PubMed 32000979Sobocinski 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.
PubMed 26806523Trimarchi 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.
PubMed 37201718
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Remodeling After Endovascular Management of Type B Aortic Dissection.
- ClinicalTrials.gov ID
- NCT06289777
- Acronym / sponsor ID
- aortic remodeling
- Conditions
- Type B Aortic Dissection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess the clinical outcome, morphological changes and behaviour of type B aortic dissection after endovascular repair.
Detailed description
Aortic dissection (AD) is considered the most common catastrophic event of the aorta, and its incidence has been reported to be ≈3/100000 per year, exceeding that of ruptured abdominal aortic aneurysm.
AD is a dynamic process and can occur anywhere along the course of the aorta, with the pathognomonic lesion being an intimal tear followed by blood surging either antegrade (typically) or retrograde, cleaving the the intima and medial layers of the aortic wall longitudinally for a variable distance, thus creating a true and false lumens.
Aortic dissections are classified by chronicity, anatomic location of false lumen, generally the entry tear and longitudinal extent, and the presence or absence of complicating features.
Temporally, AD is categorized as acute phase {<14 days}, subacute {15-90 days}, and chronic {>90 days}.
Thoracic Endovascular Aortic Repair (TEVAR) has emerged as the first-line therapy for the treatment of AD, with better short-term results than open repair due to a significant decrease in perioperative morbidity and mortality.
By covering the primary entry tear with stent-grafts, the blood flow is redirected into the true lumen, resolving malperfusion and/or preventing rupture of the false lumen, followed by its regression and re-expansion of the true lumen, which is known as "Aortic remodeling"
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- complicated or high-risk acute, subacute or chronic type B aortic dissection.
Key inclusion criteria (14 listed)
- Complicated Stanford type B dissections:
- High-risk aortic dissections:
- Aortic anatomy suitable for stent graft therapy:
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEVARminimally invasive endovascular intervention to treat aortic dissection | Procedure or surgery | – |
Primary outcome
Analysis of aortic remodeling
Time frame: 2 years
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).
technical success
Time frame: baseline
successful delivery and deployment of the device with coverage of the 1ry tear at implant with no detected endoleak on angiography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Background: PubMed 25101579Watanabe 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.
- Background: PubMed 38125333Hagedorn 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.
- Background: PubMed 18440180Rodriguez 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.
- Background: PubMed 24560244Lombardi 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.
- Background: PubMed 28081802Riambau 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.
- Background: PubMed 29914833Iannuzzi 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.
- Background: PubMed 36382952Jiang 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.
- Background: PubMed 32000979Lombardi 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.
- Background: PubMed 26806523Sobocinski 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.
- Background: PubMed 37201718Trimarchi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type B Aortic Dissection, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed h elkady, MMed (+201008182199 ext. 0882146873, mohamed.hesham.elkady@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of aortic remodeling (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06289777, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.