An interventional study of Treated with the triple branched stent graft system in Aortic Arch Aneurysm, Aortic Arch Pseudoaneurysm and Aortic Arch Ulcer, sponsored by Changhai Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Changhai Hospital · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to evaluate the safety and efficacy of the Triple Branched Covered Stent Graft System in treating aortic arch lesions. The main questions it aims to answer are:
Researchers will use a single-arm study design with predefined target values for the primary endpoints to assess the performance of the stent system.
Participants will:
27 studies on the registry are indexed under Aneurysm, Aortic Arch; 14 are open to participants now.
This study's planned enrollment of 96 is below the median of 115 across 19 interventional studies indexed under Aneurysm, Aortic Arch.
Browse Aneurysm, Aortic Arch studies →Changhai Hospital is the lead sponsor of 355 studies on the registry; 137 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients aged 18-80 years.
Anatomical conditions:
Pregnant or breastfeeding women.
Hematological abnormalities:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participant group that treated with the triple branched stent graft system
Device: Treated with the triple branched stent graft system
Participants treated with the triple branched stent graft system
12-month Treatment Success Rate
Definition: Treatment success at 12 months is defined as immediate technical success, with no device/aneurysm-related death or unplanned secondary intervention postoperatively, and no increase in the diameter of the treated aorta segment (aneurysm or ulcer lesion diameter increased by ≥5mm) due to type I/III endoleak on CTA imaging follow-up at 12 months.
Time frame: 12 months postoperatively
30-day Major Adverse Event Rate
Any of the following events occurring within 30 days: 1.All-cause death: Any death from any cause within 30 days. 2.Disabling stroke: Defined as a Modified Rankin Scale (MRS) score ≥2 due to neurological deficits, with an increase of at least one grade from baseline. 3.Persistent paraplegia: Defined as a spinal ischemia grade ≥3 according to the spinal ischemia grading system. 4.Renal failure: New-onset persistent renal failure with a creatinine increase of more than 50% above preoperative levels, requiring dialysis. 5.Myocardial infarction: Clinically diagnosed as a new acute myocardial infarction, or requiring Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG). 6.Respiratory failure: Intubation for more than 1 week during hospitalization.
Time frame: 30 days postoperatively
Immediate Technical Success Rate
The main and branch stents are successfully delivered to the predetermined position, accurately positioned and successfully deployed, the main and branch delivery systems are safely removed from the body, there is no branch stent stenosis or occlusion, and no device/aneurysm-related death or unplanned additional surgery.
Time frame: Immediately after the surgery
Branch Stent Patency Rate
Based on imaging follow-up using Digital Subtraction Angiography (DSA) or Computed Tomographic Angiography (CTA), the degree of stenosis in the branches of the brachiocephalic artery, left common carotid artery, and left subclavian artery is ≤50%.
Time frame: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively
All-cause Mortality Rate
The rate of death from any cause postoperatively.
Time frame: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively
Aortic Lesion-related Mortality Rate
The rate of death related to aortic lesions.
Time frame: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively
Paraplegia Incidence Rate
Assessed using the spinal ischemia grading system, with the grade recorded.
Time frame: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively
Stroke Incidence Rate
Assessed using the Modified Rankin Scale (MRS), with the grade recorded.
Time frame: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively
Secondary Intervention Incidence Rate
Includes open or endovascular surgery caused by type I/III endoleak, aortic growth (caused by type I/III endoleak), aortic rupture, branch stenosis or occlusion, stent migration, or new-onset dissection at the proximal or distal end, excluding planned expected surgery.
Time frame: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively
Stent Fracture/Twist/Collapse Incidence Rate
The incidence of stent fracture, twist, or collapse detected by imaging postoperatively.
Time frame: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively
Stent Migration Incidence Rate
The incidence of stent migration ≥10mm.
Time frame: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively
Endoleak Incidence Rate
Based on imaging results from DSA or CTA, the incidence of endoleak postoperatively. Endoleak is classified as follows: Type I refers to blood reflux at the proximal and distal ends of the stent; Type II refers to retrograde blood flow from the aortic branch vessels; Type III refers to blood reflux at the site of stent membrane rupture or stent connection; Type IV refers to leakage of the covered stent membrane.
Time frame: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively
Maximum Diameter and Diameter Change of Aortic Lesion
The maximum diameter of the aortic lesion segment is recorded preoperatively and during postoperative follow-up, measured perpendicular to the centerline. The proportions of maximum diameter reduction ≥5mm, maximum diameter increase ≥5mm, and maximum diameter change less than 5mm are calculated.
Time frame: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively
Plan to share: Yes
Supporting information: Study protocol
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Dec 2028, 37 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 22, 2026: start Sep 2025 → Nov 2025 and primary completion Dec 2026 → Dec 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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