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Active, not recruitingNCT05126446Updated Jul 23, 2024

the Aorta Arch Stent Graft System Combined With the Endovascular Needle System in Situ Fenestration

An interventional study of the Aorta Arch Stent Graft System combined with the Endovascular Needle System in Aortic Dissection, sponsored by Lifetech Scientific (Shenzhen) Co., Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-23.

Sponsored by Lifetech Scientific (Shenzhen) Co., Ltd. (part of LifeTech Scientific Corporation) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jul 2021, registered Nov 2021).

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Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

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.

Planned enrollment
16th of 29
120 · median 135
Started
2021
with 4 others
No phase
26 of 62
14 open now
Primary completion
2027-10
later than 19 of 28 live
Registered
25th of 62
by date
Lead sponsor
3 of 62
Lifetech Scientific (Shenzhen) Co., Ltd.

Among the 62 studies in Aortic Dissection with a site in China, this one is the 16th largest by planned enrollment of the 29 interventional ones that give a count, is one of 5 that started in 2021, is one of 26 with no phase, reaches primary completion later than 19 of the 28 other live ones, and was the 25th registered.

Aortic Dissection

205 studies on the registry are indexed under Aortic Dissection; 73 are open to participants now.

Browse Aortic Dissection studies →

Open to participants now

25 of the 62 studies in Aortic Dissection with a site in China are open now. Recruiting first, the newest first:

20 more — sign in →

All 25 open studies →

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 →

Who these studies take

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 →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 62 studies in Aortic Dissection with a site in China, or all of them as a file.
02

Study summary

A prospective, multi-center, single-group target value method to evaluate the safety and effectiveness of the Aorta Arch Stent Graft System combined with the Endovascular Needle System in situ fenestration technology in the treatment of aortic dissection involving the aortic arch

Read the detailed description
  1. Clinical trials using prospective, multi-center, single-group target value design;
  2. 120 subjects with aortic dissection requiring partial arch reconstruction will be enrolled in more than 30 centers in China, and they will meet the test enrollment requirements.
  3. CTA examination was performed at baseline, 30 days, 6 months, 12 months, 36 months, and 60 months after surgery to determine the pathological status and the status of postoperative aortic and branch revascularization
03

Conditions studied

  • Aortic Dissection

Browse trials for

Keywords

  • in situ fenestration
  • aortic dissection
  • aortic dissection involving the aortic arch
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion criteria (to be selected if all of the following criteria are met)：

  • 18 years old ≤age≤80 years old, no gender limitation;
  • Diagnosis of aortic dissection and reconstruction of the left subclavian artery;

  • The main branches and branches of the aortic arch at the lesion site have sufficient anatomical basis:

    • The diameter range of the near-end anchoring zone of the main body of the fixed mechanism: 21-46mm;
    • The length of the anchor zone near the principal part of the tunnel is ≥10mm;
    • The length of the anchor zone of the branching vessel of the convex target is ≥15mm;
    • The diameter range of the distal anchoring zone of the target branching vessel is 5-18mm.
  • The patient has adequate surgical access vessels;
  • Patients who understand the purpose of the study, voluntarily participate in and sign , and are willing to follow up.

Exclusion Criteria (If one of the following criteria is met, it will not be selected)：

  • The patient is pregnant or breastfeeding;
  • The patient had a history of cardiac surgery (congenital heart disease surgery, heart valve surgery, coronary heart disease surgery, thoracic aortic surgery, etc.), which would affect the implementation of this TEVAR surgery;
  • The patient has been implanted or planned to be implanted with left ventricular auxiliary pump, interventional valve and other instruments, or is planning to undergo coronary intervention surgery, and aortic dissection is expected to affect the function of such instruments or such instruments will affect the operation of aortic dissection;
  • Patients with severe hematoma on the aortic wall in the proximal anchoring area of the stent;
  • Marfan syndrome and other connective tissue diseases, arteritis;
  • Patients with a history of allergy to contrast agents, anesthetics, antiplatelet drugs, anticoagulants, nickel peptide alloys, and polytetrafluoroethylene materials;
  • Patients with a history of cerebral infarction or myocardial infarction within 3 months before surgery;
  • Patients with active bleeding and coagulopathy;
  • Abnormal renal function: patients with preoperative creatinine > 2.5 times the normal upper limit value;
  • Abnormal liver function: patients with (ALT) or aspartate aminotransferase (AST) > 5 times the normal upper limit value, or patients with serum total (STB) > 2 times the normal upper limit value;
  • Patients with end-stage diseases with a of less than one year;
  • patients with poor compliance considered by the investigator;
  • Patients participating in other clinical trials at the same time.
Terms in these criteria, in plain language(4)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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.

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.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    aortic dissection involving the aortic arch

    Aortic dissection involving the aortic arch was diagnosed in patients requiring revascularization of the aortic arch and its branches

    Device: the Aorta Arch Stent Graft System combined with the Endovascular Needle System

Interventions

  • Devicethe Aorta Arch Stent Graft System combined with the Endovascular Needle System

    Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with device

06

What researchers measure

Primary outcomes

  1. Primary safety end point of the Aorta Arch Stent Graft System: no Major Adverse events（MAE） occurrence within 30 days after surgery

    MAE was defined as death related to aortic dissection, ischemic stroke, and paraplegia within 30 days after surgery

    Time frame: Within 30 days after procedure

  2. Primary efficacy endpoint of the Aorta Arch Stent Graft System: treatment success at 12 months after surgery

    On the basis of successful surgery, the main and branch stents were unobstructed 12 months after surgery, with no internal leakage requiring intervention, no stent displacement (displacement ≤10mm), no new device-related rupture, and no device-induced aortic arch re-operation

    Time frame: 12 months after procedure

  3. Primary endpoint of the Endovascular Needle System: Immediate surgical success rate of the Endovascular Needle System

    Intraoperative DSA, the membrane was successfully broken in situ with the membrane rupture system, and the membrane rupture system was successfully withdrawn

    Time frame: intraoperative

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2021 (actual). Primary completion is estimated for Oct 2027, 75 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 75 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 8, 2021
First posted
Nov 19, 2021
StartActual
Jul 25, 2021
Primary completionEst.
Oct 30, 2027
CompletionEst.
Mar 30, 2028
Last update
Jul 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05126446
Lead sponsor
Lifetech Scientific (Shenzhen) Co., Ltd.
Responsible party
Sponsor
First posted
Nov 19, 2021
Start date
Jul 25, 2021
Primary completion
Oct 30, 2027 (estimated)
Completion
Mar 30, 2028 (estimated)
Last update
Jul 23, 2024

Study contacts

Chang Shu, Professor
principal investigator · Xiangya Second Hospital, Central South University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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