Aortic Aneurysm and DissectionNCT07697820
Outcomes of Left Subclavian Artery Revascularization Strategies During Zone 2 Thoracic Endovascular Aortic Repair
A study testing Bypass graft in people with Aortic Aneurysm and Dissection, run by Assiut University.
Trial summary
Intentional coverage of left subclavian artery (LSA) is often necessary during thoracic endovascular aortic repair (TEVAR) to secure an adequate proximal landing zone. However, this may impair blood flow to vital vascular territories with increased risk of stroke, spinal cord ischemia and upper limb ischemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm and Dissection
- What is being tested?
- Bypass graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 years Undergoing TEVAR with proximal landing in zone 2 whether acute or chronic type B aortic dissection (TBAD), thoraco-abdominal aortic aneurysm (TAAA), penetrating aortic ulcer (PAU) or intramural hematoma (IMH).
- Treatment with one of the following:
- Single-branched stent grafts
- In-situ fenestration (e.g. ISLF ± stent)
- Chimney/periscope graft techniques
- Physician-modified endografts (PMEGs)
- Carotid-subclavian bypass, carotid-axillary bypass, or subclavian transposition
Who cannot join
- • Non revascularized left subclavian artery.
- Zone 0 or 1 procedures
- Multi-vessel arch debranching
- Blunt traumatic aortic injury (BTAI)
- Incomplete imaging or follow-up data
About this study
Intentional coverage of left subclavian artery (LSA) is often necessary during thoracic endovascular aortic repair (TEVAR) to secure an adequate proximal landing zone. However, this may impair blood flow to vital vascular territories with increased risk of stroke, spinal cord ischemia and upper limb ischemia.
Current recommendations from the Society for Vascular Surgery (SVS) and European Society for Vascular Surgery (ESVS) support the consideration of LSA revascularization in patients undergoing elective TEVAR with anticipated LSA coverage. In contrast, management in the acute setting is more complex and requires an individualized approach based on clinical urgency and anatomical factors. Revascularization is generally recommended in high-risk clinical scenarios, including patients with dominant left vertebral circulation, compromised or occluded contralateral vertebral artery, an incomplete circle of Willis, or variant vertebral anatomy such as a hypoplastic left vertebral artery terminating in the posterior inferior cerebellar artery or an isolated vertebral artery. Additional indications include prior LIMA grafting, the presence of upper limb dialysis access, anticipated extensive aortic coverage, or an aberrant right subclavian artery in which both subclavian origins may be compromised.
Read more
Revascularization techniques encompass both open surgical and endovascular approaches. Surgical options include carotid-subclavian bypass, carotid-axillary bypass, and subclavian transposition, while endovascular methods involve branched or fenestrated endografts, chimney and periscope grafts, as well as in situ fenestration. Although surgical techniques provide durable long-term patency, they are associated with a risk of local complications. Endovascular approaches are minimally invasive; however, they may be associated with an increased risk of endoleaks.
Anatomical factors also play a central role in determining both the feasibility and outcomes. Preoperative assessment using computed tomography angiography is essential to evaluate aortic arch morphology, proximal landing zone characteristics, branch vessel orientation, and access vessel suitability. In addition, the spatial relationship between the left common carotid artery (LCCA) and LSA, including minimum inter-vessel distances, directly influences the feasibility of branched or fenestrated endografts. Also branch vessel anatomy is equally critical, as LSA diameter, vertebral artery origin, and vessel length determine the suitability for branch incorporation or fenestration techniques. Furthermore, access-related anatomical constraints, particularly iliofemoral vessel diameter and calcification, may significantly limit device delivery.
- Conditions
- Aortic Aneurysm and Dissection
- Being tested
- Bypass graft
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bypass graftProcedure or surgery
Carotid subclavian bypass
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Active comparator | Bypass Receives: Procedure: Bypass graft |
| Endovascular | Active comparator | Branched endograft Receives: Procedure: Bypass graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants achieving technical success
Technical success is defined as successful stent graft deployment in the intended position with complete exclusion of the target aortic pathology, maintenance of left subclavian artery patency, absence of type I or III endoleak on completion angiography, and no intraoperative major adverse events (stroke, aortic rupture, or death). Results will be reported as the number and percentage of participants achieving technical success.
Measured: 30 days
Number of participants experiencing perioperative complications or requiring reintervention
Perioperative outcomes include stroke, spinal cord ischemia, upper limb ischemia, myocardial infarction, access-related complications, aortic rupture, death, endoleak requiring treatment, and any unplanned surgical or endovascular reintervention occurring within 30 days after TEVAR. Results will be reported as the number and percentage of participants experiencing one or more events.
Measured: 30 days
Secondary outcomes (3)
Number of participants with primary left subclavian artery patency at 3 years
Primary left subclavian artery patency is defined as uninterrupted patency of the left subclavian artery without any surgical or endovascular reintervention during the 3-year follow-up period. Patency will be assessed by computed tomography angiography (CTA) or duplex ultrasound. The outcome will be reported as the number and percentage of participants with primary left subclavian artery patency.
Measured: 3 years
Number of participants with assisted primary or secondary left subclavian artery patency
Assisted primary patency is defined as maintained LSA patency after an intervention performed before occlusion, while secondary patency is defined as restoration of flow after occlusion. Patency will be assessed by CTA or duplex ultrasound. Results will be reported as the number and percentage of participants maintaining assisted primary or secondary patency.
Measured: 3 years
Number of participants requiring left subclavian artery reintervention
LSA-related reintervention includes any surgical or endovascular procedure performed to maintain assisted primary patency or restore secondary patency, including angioplasty, stenting, thrombectomy, bypass revision, or redo bypass. Results will be reported as the number and percentage of participants requiring one or more reinterventions.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Aneurysm and 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Tarek Mostafa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697820
- Sponsor's protocol ID
- TEVAR
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
1. Feezor RJ, Martin TD, Hess PJ, Klodell CT, Beaver TM, Huber TS, et al. Risk factors for perioperative stroke during thoracic endovascular aortic repairs (TEVAR). J Endovasc Ther. 2007 Aug;14(4):568-73. doi:10.1177/152660280701400420 PubMed PMID: 17696634. 2. Matsumura JS, Lee WA, Mitchell RS, Farber MA, Murad MH, Lumsden AB, et al. The Society for Vascular Surgery Practice Guidelines: management of the left subclavian artery with thoracic endovascular aortic repair. J Vasc Surg. 2009 Nov;50(5):1155-8. doi:10.1016/J.JVS.2009.08.090 PubMed PMID: 19878791. 3. Wanhainen A, Gombert A, Antoniou GA, Fidalgo Domingos LA, Gouveia e Melo R, Grabenwöger M, et al. European Society for Vascular Surgery (ESVS) 2026 Clinical Practice Guidelines on the Management of Descending Thoracic and Thoraco-Abdominal Aortic Diseases. European Journal of Vascular and Endovascular Surgery. 2025 Feb 1;71(2):172-270. doi:10.1016/J.EJVS.2025.12.050/ATTACHMENT/4919EBC3-7A5C-48FD-9138-D4C9AB08CE0D/MMC3.PDF PubMed PMID: 41448425. 4. Upchurch GR, Escobar GA, Azizzadeh A, Beck AW, Conrad MF, Matsumura JS, et al. Society for Vascular Surgery clinical practice guidelines of thoracic endovascular aortic repair for descending thoracic aortic aneurysms. J Vasc Surg. 2021 Jan 1;73(1):55S-83S. doi:10.1016/J.JVS.2020.05.076/ASSET/A831C192-C4DD-4DCB-9701-3DD23F180CA0/MAIN.ASSETS/GR2.JPG PubMed PMID: 32628988. 5. Lin F, He Z, Gao J, Huang X, Wang H, Han L, et al. Comparison of surgical and endovascular left subclavian artery revascularization during thoracic aortic endovascular repair: a systematic review and meta-analysis. Front Cardiovasc Med. 2023 Nov 2;10:1274629. doi:10.3389/FCVM.2023.1274629/TEXT 6. Scali ST, Chang CK, Pape SG, Feezor RJ, Berceli SA, Huber TS, et al. Subclavian revascularization in the age of thoracic endovascular aortic repair and comparison of outcomes in patients with occlusive disease. J Vasc Surg. 2013 Oct;58(4):901-9. doi:10.1016/J.JVS.2013.04.005 PubMed PMID: 23711694.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Left Subclavian Artery Revascularization Strategies During Zone 2 Thoracic Endovascular Aortic Repair
- ClinicalTrials.gov ID
- NCT07697820
- Acronym / sponsor ID
- TEVAR
- Conditions
- Aortic Aneurysm and Dissection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 13 Jul 2026 (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.
Intentional coverage of left subclavian artery (LSA) is often necessary during thoracic endovascular aortic repair (TEVAR) to secure an adequate proximal landing zone. However, this may impair blood flow to vital vascular territories with increased risk of stroke, spinal cord ischemia and upper limb ischemia.
Current recommendations from the Society for Vascular Surgery (SVS) and European Society for Vascular Surgery (ESVS) support the consideration of LSA revascularization in patients undergoing elective TEVAR with anticipated LSA coverage. In contrast, management in the acute setting is more complex and requires an individualized approach based on clinical urgency and anatomical factors. Revascularization is generally recommended in high-risk clinical scenarios, including patients with dominant left vertebral circulation, compromised or occluded contralateral vertebral artery, an incomplete circle of Willis, or variant vertebral anatomy such as a hypoplastic left vertebral artery terminating in the posterior inferior cerebellar artery or an isolated vertebral artery. Additional indications include prior LIMA grafting, the presence of upper limb dialysis access, anticipated extensive aortic coverage, or an aberrant right subclavian artery in which both subclavian origins may be compromised.
Revascularization techniques encompass both open surgical and endovascular approaches. Surgical options include carotid-subclavian bypass, carotid-axillary bypass, and subclavian transposition, while endovascular methods involve branched or fenestrated endografts, chimney and periscope grafts, as well as in situ fenestration. Although surgical techniques provide durable long-term patency, they are associated with a risk of local complications. Endovascular approaches are minimally invasive; however, they may be associated with an increased risk of endoleaks.
Anatomical factors also play a central role in determining both the feasibility and outcomes. Preoperative assessment using computed tomography angiography is essential to evaluate aortic arch morphology, proximal landing zone characteristics, branch vessel orientation, and access vessel suitability. In addition, the spatial relationship between the left common carotid artery (LCCA) and LSA, including minimum inter-vessel distances, directly influences the feasibility of branched or fenestrated endografts. Also branch vessel anatomy is equally critical, as LSA diameter, vertebral artery origin, and vessel length determine the suitability for branch incorporation or fenestration techniques. Furthermore, access-related anatomical constraints, particularly iliofemoral vessel diameter and calcification, may significantly limit device delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | Active comparator | Procedure: Bypass graftBypass |
| Endovascular | Active comparator | Procedure: Bypass graftBranched endograft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients ≥18 years Undergoing TEVAR with proximal landing in zone 2 whether acute or chronic type B aortic dissection (TBAD), thoraco-abdominal aortic aneurysm (TAAA), penetrating aortic ulcer (PAU) or intramural hematoma (IMH).
- Treatment with one of the following:
- Single-branched stent grafts
- In-situ fenestration (e.g. ISLF ± stent)
- Chimney/periscope graft techniques
Key exclusion criteria (5 listed)
- • Non revascularized left subclavian artery.
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 |
|---|---|---|
| Bypass graftCarotid subclavian bypass | Procedure or surgery | Endovascular, Surgery |
Primary outcome
Number of participants achieving technical success
Time frame: 30 days
Technical success is defined as successful stent graft deployment in the intended position with complete exclusion of the target aortic pathology, maintenance of left subclavian artery patency, absence of type I or III endoleak on completion angiography, and no intraoperative major adverse events (stroke, aortic rupture, or death). Results will be reported as the number and percentage of participants achieving technical success.
Number of participants experiencing perioperative complications or requiring reintervention
Time frame: 30 days
Perioperative outcomes include stroke, spinal cord ischemia, upper limb ischemia, myocardial infarction, access-related complications, aortic rupture, death, endoleak requiring treatment, and any unplanned surgical or endovascular reintervention occurring within 30 days after TEVAR. Results will be reported as the number and percentage of participants experiencing one or more events.
3 secondary outcomes
Number of participants with primary left subclavian artery patency at 3 years
Time frame: 3 years
Number of participants with assisted primary or secondary left subclavian artery patency
Time frame: 3 years
Number of participants requiring left subclavian artery reintervention
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Background1. Feezor RJ, Martin TD, Hess PJ, Klodell CT, Beaver TM, Huber TS, et al. Risk factors for perioperative stroke during thoracic endovascular aortic repairs (TEVAR). J Endovasc Ther. 2007 Aug;14(4):568-73. doi:10.1177/152660280701400420 PubMed PMID: 17696634. 2. Matsumura JS, Lee WA, Mitchell RS, Farber MA, Murad MH, Lumsden AB, et al. The Society for Vascular Surgery Practice Guidelines: management of the left subclavian artery with thoracic endovascular aortic repair. J Vasc Surg. 2009 Nov;50(5):1155-8. doi:10.1016/J.JVS.2009.08.090 PubMed PMID: 19878791. 3. Wanhainen A, Gombert A, Antoniou GA, Fidalgo Domingos LA, Gouveia e Melo R, Grabenwöger M, et al. European Society for Vascular Surgery (ESVS) 2026 Clinical Practice Guidelines on the Management of Descending Thoracic and Thoraco-Abdominal Aortic Diseases. European Journal of Vascular and Endovascular Surgery. 2025 Feb 1;71(2):172-270. doi:10.1016/J.EJVS.2025.12.050/ATTACHMENT/4919EBC3-7A5C-48FD-9138-D4C9AB08CE0D/MMC3.PDF PubMed PMID: 41448425. 4. Upchurch GR, Escobar GA, Azizzadeh A, Beck AW, Conrad MF, Matsumura JS, et al. Society for Vascular Surgery clinical practice guidelines of thoracic endovascular aortic repair for descending thoracic aortic aneurysms. J Vasc Surg. 2021 Jan 1;73(1):55S-83S. doi:10.1016/J.JVS.2020.05.076/ASSET/A831C192-C4DD-4DCB-9701-3DD23F180CA0/MAIN.ASSETS/GR2.JPG PubMed PMID: 32628988. 5. Lin F, He Z, Gao J, Huang X, Wang H, Han L, et al. Comparison of surgical and endovascular left subclavian artery revascularization during thoracic aortic endovascular repair: a systematic review and meta-analysis. Front Cardiovasc Med. 2023 Nov 2;10:1274629. doi:10.3389/FCVM.2023.1274629/TEXT 6. Scali ST, Chang CK, Pape SG, Feezor RJ, Berceli SA, Huber TS, et al. Subclavian revascularization in the age of thoracic endovascular aortic repair and comparison of outcomes in patients with occlusive disease. J Vasc Surg. 2013 Oct;58(4):901-9. doi:10.1016/J.JVS.2013.04.005 PubMed PMID: 23711694.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bypass graft in people with Aortic Aneurysm and Dissection, run by Assiut University.
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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants achieving technical success (time frame: 30 days). 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 NCT07697820, which also lists 1 linked publication.
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 13 Jul 2026.