Aortic Arch DiseaseNCT07139912
Prospective, Multicenter, Single-Arm Study of Aortic Arch Pathology Reconstruction
A study testing Thoracic Aortic Multi-Branch Stent Graft System in people with Aortic Arch Disease, run by Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd at 1 site in China.
Trial summary
A prospective ,multiple center Study about the Safety and Efficacy of the Thoracic Aortic Multi-Branch Stent Graft System, developed and manufactured by Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd., in patients with aortic arch pathologies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Arch Disease
- What is being tested?
- Thoracic Aortic Multi-Branch Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- Sep 2025to Mar 2032
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 80 years
- Diagnosed with aortic arch pathology requiring intervention, including:
- True aortic arch aneurysm
- Pseudoaneurysm of the aortic arch
- Penetrating aortic ulcer involving the arch
- Deemed suitable for endovascular repair by the investigating physician
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- Capable of understanding study objectives, providing written informed consent, and complying with follow-up requirements
- Anatomic suitability confirmed by CTA:
- Ascending aortic length ≥50 mm
- Ascending aortic diameter ≥26 mm and ≤46 mm
- Proximal landing zone length ≥20 mm
- Brachiocephalic trunk diameter ≥9 mm and ≤19 mm with length ≥20 mm
- Left common carotid artery (LCCA) and left subclavian artery (LSA) diameters ≥5 mm and ≤13 mm
- LCCA length ≥20 mm
- Distance from LSA ostium to left vertebral artery origin ≥20 mm
- High surgical risk per investigator assessment OR contraindicated for open surgery
Who cannot join
- Pregnant or lactating women
- Connective tissue disorders affecting the aorta (e.g., Marfan syndrome, Ehlers-Danlos syndrome)
- Infected aortic pathologies or aortitis (e.g., mycotic aneurysm, Takayasu arteritis)
- Prior endovascular repair of ascending aorta/aortic arch
- Documented allergy to nitinol, contrast media, or device materials
- Severe renal impairment:(Serum creatinine >2×ULN,Excluding dialysis-dependent patients)
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- Hematologic abnormalities:(WBC <3×10⁹/L、Hb <70 g/L、PLT <50×10⁹/L)
- Heart transplant recipients
- Myocardial infarction or stroke within 3 months
- NYHA Class IV heart failure
- Active systemic infection (e.g., bacteremia, sepsis)
- Life expectancy <12 months
- Mechanical aortic valve prosthesis impeding device delivery
- Current participation in other interventional trials with primary endpoint pending
- Anticipated poor compliance with follow-up
- Other contraindications for endovascular repair per investigator assessment:Severe vascular stenosis/calcification/tortuosity/Thrombus at landing zones/Inability to cooperate with procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Changhai Hospital
Shanghai
Doctor Lu, +86 0213112185, luqs@xueguan.net
About this study
Official title: Prospective, Multicenter, Single-Arm Trial Assessing Safety/Effectiveness of Multi-Branch Thoracic Stent Grafts in Aortic Arch Disease
A prospective ,multiple center Study about the Safety and Efficacy of the Thoracic Aortic Multi-Branch Stent Graft System, developed and manufactured by Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd., in patients with aortic arch pathologies.
- Conditions
- Aortic Arch Disease
- Being tested
- Thoracic Aortic Multi-Branch Stent Graft System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic Aortic Multi-Branch Stent Graft SystemDevice
The Thoracic Aortic Multi-Branch Stent Graft Systemm consists of the Single-Branch Aortic Stent-Graft System, the aortic extension stent graft system and the branch stent system.
| Study group | Role | What they receive |
|---|---|---|
| Participant Group/Arm | Experimental | Participants will be treated with Thoracic Aortic Multi-Branch Stent Graft System, developed and manufactured by Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd Receives: Device: Thoracic Aortic Multi-Branch Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month treatment success rate
Technical success at the index procedure, without device- or aortic pathology-related mortality or unplanned secondary interventions, and with no evidence of persistent enlargement of the treated aortic segment due to Type I/III endoleaks on 12-month CTA follow-up.
Measured: 12-month
30-day rate of Major Adverse Events (MAE)
Including all-cause mortality, disabling stroke, persistent paraplegia, renal failure, myocardial infarction, and respiratory failure
Measured: 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Arch DiseaseStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139912
- Sponsor's protocol ID
- Endovastec
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Single-Arm Trial Assessing Safety/Effectiveness of Multi-Branch Thoracic Stent Grafts in Aortic Arch Disease
- ClinicalTrials.gov ID
- NCT07139912
- Acronym / sponsor ID
- Endovastec
- Conditions
- Aortic Arch Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Shanghai MicroPort Endovascular MedTech（Group）Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2025 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 24 Aug 2025 (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.
A prospective ,multiple center Study about the Safety and Efficacy of the Thoracic Aortic Multi-Branch Stent Graft System, developed and manufactured by Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd., in patients with aortic arch pathologies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant Group/Arm | Experimental | Device: Thoracic Aortic Multi-Branch Stent Graft SystemParticipants will be treated with Thoracic Aortic Multi-Branch Stent Graft System, developed and manufactured by Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Aged 18 to 80 years
- Diagnosed with aortic arch pathology requiring intervention, including:
- True aortic arch aneurysm
- Pseudoaneurysm of the aortic arch
- Penetrating aortic ulcer involving the arch
Key exclusion criteria (16 listed)
- Pregnant or lactating women
- Connective tissue disorders affecting the aorta (e.g., Marfan syndrome, Ehlers-Danlos syndrome)
- Infected aortic pathologies or aortitis (e.g., mycotic aneurysm, Takayasu arteritis)
- Prior endovascular repair of ascending aorta/aortic arch
- Documented allergy to nitinol, contrast media, or device materials
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 |
|---|---|---|
| Thoracic Aortic Multi-Branch Stent Graft SystemThe Thoracic Aortic Multi-Branch Stent Graft Systemm consists of the Single-Branch Aortic Stent-Graft System, the aortic extension stent graft system and the branch stent system. | Device | Participant Group/Arm |
Primary outcome
12-month treatment success rate
Time frame: 12-month
Technical success at the index procedure, without device- or aortic pathology-related mortality or unplanned secondary interventions, and with no evidence of persistent enlargement of the treated aortic segment due to Type I/III endoleaks on 12-month CTA follow-up.
30-day rate of Major Adverse Events (MAE)
Time frame: 30-day
Including all-cause mortality, disabling stroke, persistent paraplegia, renal failure, myocardial infarction, and respiratory failure
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 24 Aug 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic Aortic Multi-Branch Stent Graft System in people with Aortic Arch Disease, run by Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd at 1 site in China.
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 16 inclusion and 16 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 24 Aug 2025. 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 China. 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?
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?
Contact Qingsheng Lu (021-31162185, luqs@newvascular.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-month treatment success rate (time frame: 12-month). 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?
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 24 Aug 2025.