An interventional study of Aortic Arch Single Branch Covered Stent System in Aortic Dissection, sponsored by Lifetech Scientific (Shenzhen) Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-06-11.
Sponsored by Lifetech Scientific (Shenzhen) Co., Ltd. (part of LifeTech Scientific Corporation) · Not applicable, Interventional, and Other
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Among 62 studies in Aortic Dissection with a site in China — 25 open to participants now, 29 under way, 1 of them phase 3. Aortic Dissection · China.
Among the 62 studies in Aortic Dissection with a site in China, this one is the 15th largest by planned enrollment of the 29 interventional ones that give a count, is one of 6 that started in 2025, is one of 26 with no phase, reaches primary completion later than 14 of the 28 other live ones, and was the 50th registered.
205 studies on the registry are indexed under Aortic Dissection; 73 are open to participants now.
Browse Aortic Dissection studies →25 of the 62 studies in Aortic Dissection with a site in China are open now. Recruiting first, the newest first:
Hangzhou Endonom Medtech Co., Ltd. · Sites in China
Ages 18–80
DeltaHealth Hospital · Shanghai · Sites in China
Ages 16–55 · Women only
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Sites in China
Ages 18–65
Nanjing Medical University · Sites in China
Ages 18–90
Yong Lin, PhD · Sites in China
Ages 14–70
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 44 Aortic Dissection studies recruiting now, 27 (61%) set no upper age limit and 5 (11%) stop at 75 or younger; 9 take children under 18; 5 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
62 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 6 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 135 is above the median of 114 across 86 interventional studies indexed under Aortic Dissection.
Median enrollment 135 across the 29 interventional studies, 260 across the 33 observational. Of the 12 that completed or were terminated, 1 (8%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 62 have an industry lead sponsor. The 10 most frequent:
This study is registered under Lifetech Scientific (Shenzhen) Co., Ltd., one of the names counted as LifeTech Scientific Corporation. Under that name alone:
Lifetech Scientific (Shenzhen) Co., Ltd. is the lead sponsor of 44 studies on the registry; 17 are open to participants now.
LifeTech Scientific Corporation has 3 studies filed under Aortic Dissection — fewer than ten, so there is no comparison to draw.
7 of the studies in Aortic Dissection with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06968806Phase 3The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolStudy on Ketorolac for Improving Outcomes and Prognosis in Patients With Stanford Type A Aortic Dissection | 2027-09-01 |
| NCT06966687Nanjing Medical UniversityProtective Effect of Ulinastatin and Thymosin α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA XI) | 2026-12-31 |
| NCT06915545Lifetech Scientific (Shenzhen) Co., Ltd.Study on the Aortic Arch Single Branch Stent Graft System | 2027-04-30 |
| NCT07362901First Affiliated Hospital of Zhejiang UniversityEffects of Precise Education on Postoperative Discomfort Symptoms in Patients With Aortic Disease Undergoing Endovascular Intervention: a Single-center Randomized Controlled Study | 2027-06-01 |
| NCT07603037First Affiliated Hospital of Wannan Medical CollegeEIT Evaluation of Different Antihypertensive Agents on the Ventilation-Perfusion Ratio in Patients With Acute Respiratory Failure | 2027-07-30 |
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Among the 62 studies in Aortic Dissection with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The objective of the study is to evaluate the Safety and Efficacy of Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch
The physician shall strictly follow the clinical study protocol and shall not deviate from or substantially change the protocol. However, in case of emergency such as immediate risk to the subjects, which needs tobe eliminated immediately, it may be reported in written form afterwards. During the course of the study,documents such as amendments to the clinical study protocol and informed consent, requests for deviation,and resumption of the suspended clinical study shall be subject to the written approval of the Ethics Committee
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.
Anatomical criteria:
Exclusion Criteria:
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 “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
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.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
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.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch
Device: Aortic Arch Single Branch Covered Stent System
to Evaluate the Safety and Efficacy of the Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch
Incidence rate for freedom from major adverse events (MAE) within 30 days postoperatively
Major adverse events refer to the occurrences of all-cause death, myocardial infarction, renal failure, liver failure, respiratory failure, paraplegia, ischemic stroke, intestinal necrosis. Among them, renal failure means that it leads to persistent dialysis, kidney transplantation, or other fatal outcomes. Respiratory failure means that it leads to a significantly prolonged intubation time, tracheotomy, deterioration of lung function, or other fatal outcomes. Intestinal necrosis refers to intestinal ischemia that requires intestinal resection or leads to other fatal outcomes.
Time frame: pre-discharge up to 14 days and 30 days post-surgery
Procedural success rate of aortic dissection treatment 12 months postoperatively
The composite endpoints include immediate technical success post-procedure and, at the 12-month CTA reexamination, the absence of displacement of the main aortic and branch stents, no type I or III endoleaks, patency of the branch stents, and no secondary surgical interventions during follow-up.
Time frame: intraoperative and 12 months postoperatively
All-cause mortality
All-cause mortality Refers to deaths from any cause that occur within the follow-up time points.
Time frame: Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively
Mortality rate related to aortic dissection
Mortality rate related to aortic dissection refers to the death caused by the rupture of aortic dissection or the endovascular treatment of aortic dissection.
Time frame: Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively
Incidence rate of severe adverse events
Serious adverse events refer to those occurring during the process of a clinical trial that lead to death or a serious deterioration of the health condition. This includes fatal diseases or injuries, permanent defects in body structures or body functions, the need for hospitalization or an extended hospital stay, and the requirement for medical or surgical interventions to prevent permanent defects in body structures or body functions.
Time frame: Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively
Incidence rate of Device-related adverse events
Adverse events refer to adverse medical events that occur during the process of a clinical trial, regardless of whether they are related to the medical device used in the trial. However, normal postoperative stress responses should be distinguished, such as fever, discomfort in the chest and back, etc. If, upon the judgment of the researcher, it is determined to be a normal postoperative stress response, there is no need to record it as an adverse event of the medical device. Adverse events related to the medical device refer to situations that are determined by the researcher to be definitely related, possibly related, or undeterminable in relation to the medical device used in the trial.
Time frame: Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively
The incidence rate of left upper limb ischemia
Left upper limb ischemia may present with weakness, coldness, pain, and numbness in the left upper limb. The ulnar artery, radial artery, and brachial artery may show weakened or absent pulsation.
Time frame: Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively
Incidence rate of Type I/III endoleak
A Type I endoleak occurs when there is a gap between the graft and the vessel wall at the "seal zones." This gap allows blood to flow alongside the graft into the aneurysm sac, creating pressure within the sac and increasing the risk of rupture. Type I endoleaks often occur when the aneurysm's anatomy is unsuitable for endovascular aneurysm repair (EVAR) or due to inappropriate device selection. However, vessel dilation over time can also cause this type of endoleak. Immediate attention is typically required because of the high risk of sac enlargement and rupture.
Time frame: Intraoperative, pre-discharge（up to 14 days）, within 30 days and 6 and 12 months postoperatively
Incidence rate of stent graft migration
Migration is defined as the single branched covered stent system of the aortic arch having a displacement of more than 10 mm compared with its position before discharge .
Time frame: 6 and 12 months postoperatively
The patency rate of the branch vessel
Branch vessel patency is defined as stenosis of ≤50%
Time frame: Pre-discharge up to 14 days, 6 and 12 months postoperatively
The success rate of vascular remodeling for aortic dissection
Evaluate the expansion of the true lumen and the thrombosis of the false lumen at the sites covered by the vascular stents for aortic dissection, so as to determine whether the vascular remodeling is successful.
Time frame: within 30 days and 6 and 12 months postoperatively
The incidence rate of conversion to thoracotomy or secondary interventional surgery due to aortic dissection
Evaluate whether the subjects have been converted to thoracotomy or secondary interventional surgery due to aortic dissection.
Time frame: Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Apr 2027, 24 months after the start.
Of 49 interventional studies with no phase under Aortic Dissection, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
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