Thoracoabdominal Aortic Stent System for Endovascular Treatment of Thoracoabdominal Aortic Dissecting Aneurysm.

Last updated: June 17, 2025
Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Cardiovascular Disease

Aneurysm

Treatment

Thoracoabdominal aortic stent system

Clinical Study ID

NCT05803564
Guard-FIM-01
  • Ages 18-80
  • All Genders

Study Summary

A First in man study to evaluate the safety and efficacy of thoracoabdominal aortic stent system for endovascular treatment of thoracoabdominal aortic dissecting aneurysm.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients aged greater than 18 years old and less than 80 years old;

  2. Patients diagnosed with thoraco-abdominal aortic dissecting aneurysm and at leastone of the following conditions should be met: a)Maximum aneurysm diameter >50 mm; b)Increase in diameter by more than 5 mm inrecent 6 months c)Symptoms such as abdominal pain and back pain associated withthoracic and abdominal aortic dissecting aneurysm were identified. d)Poor morphology of thoracic and abdominal aortic dissecting aneurysm; e)Aorticdissection tears to iliac artery resulting in common iliac artery dissection tumordiameter >40 mm;

  3. Anatomic criteria a)The diameter of the proximal anchoring area (aorta or implanted graft) ranged from 1736 mm to ≥25 mm in length; b)Distal anchoring area (aorta or implanted graft): Ifdistal anchoring area is in iliac artery, anchoring area diameter range 725 mm,length ≥15 mm; If the distal anchoring area is in the abdominal aorta, the anchoringarea has a diameter of 1236 mm and a length of ≥20 mm; c)There is a normalanchoring area at the distal end of the visceral branch vessel. The diameter rangeof the anchoring area is 613 mm and the length is ≥15 mm. d)Normal anchoring zone at distal renal artery, anchoring zone diameter 4.5~9 mm,length ≥15 mm; e)Suitable iliac, femoral, and upper limb arterial access.

  4. Patients who understand the purpose of the trial, volunteer to participate and signthe informed consent form, and are willing to complete follow-up as required by theprotocol;

Exclusion

Exclusion Criteria:

  1. Patients with severe hematoma in aortic wall in proximal anchoring area of stent

  2. Patients requiring simultaneous coverage and embolization of bilateral internaliliac arteries;

  3. Patients with a history of acute coronary syndrome within 6 months; Acute coronarysyndromes are cardiac acute ischemic syndromes resulting from rupture of an unstableatherosclerotic plaque in the coronary artery or erosion secondary to the formationof new blood 4 thrombus, including ST-elevation myocardial infarction,non-ST-elevation myocardial infarction, and unstable angina.

  4. Patients with a transient ischemic attack (TIA) or ischemic/hemorrhagic strokewithin 3 months;

  5. Patients with preoperative hepatic and renal dysfunction [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the normal upper limit; Serumcreatinine (Cr) >150u mol/L];

  6. Patients with severe pulmonary insufficiency who cannot tolerate general anesthesia;

  7. Patients with severe coagulopathy;

  8. Patients with a history of hypersensitivity to contrast agents, anticoagulants,antiplatelet agents, stent delivery devices (i.e., nitinol, polyester, PTFE, nylonpolymer materials);

  9. Patients with connective tissue diseases such as systemic lupus erythematosus,Marfan syndrome, Egyptian syndrome, or Behcet's disease;

  10. Patients with arteritis;

  11. Patients with significant organ dysfunction or other serious disease;

  12. Women with planned pregnancy, pregnancy stage , or lactation;

  13. The patient participated in another clinical trial and was not out or withdrawnwithin the first 3 months of the screening period of this trial.

  14. Patients with a life expectancy of not more than 1 year;

  15. Patients judged by the investigator to be unsuitable for endovascular treatment;

Study Design

Total Participants: 46
Treatment Group(s): 1
Primary Treatment: Thoracoabdominal aortic stent system
Phase:
Study Start date:
October 01, 2021
Estimated Completion Date:
October 01, 2027

Study Description

The study is mainly for patients with thoraco-abdominal aortic dissecting aneurysm, and all subjects who passed the screening and signed the informed consent will be enrolled. Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with thoracoabdominal aortic stent system. Patients will be followed up at discharge, 1 month, 6 months, 12 months after the implantation.

Connect with a study center

  • Chinese PLA General Hospita

    Beijing, Beijing
    China

    Active - Recruiting

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