Clinical trial NCT05803564: Thoracoabdominal Aortic Stent System for Endovascular Treatment of Thoracoabdominal Aortic Dissecting Aneurysm.
Official title: Clinical Application of a New Technique of Thoracoabdominal Aortic Stent System for Endovascular Treatment of Thoracoabdominal Aortic Dissecting Aneurysm.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thoracoabdominal; Aortic, Aneurysm, Dissecting
Keywords: Thoracoabdominal aortic stent system
thoracoabdominal aortic dissecting aneurysm
G-Branch
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-07
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 least one of the following conditions should be met:

   a)Maximum aneurysm diameter \>50 mm; b）Increase in diameter by more than 5 mm in recent 6 months c）Symptoms such as abdominal pain and back pain associated with thoracic and abdominal aortic dissecting aneurysm were identified.

   d）Poor morphology of thoracic and abdominal aortic dissecting aneurysm; e）Aortic dissection tears to iliac artery resulting in common iliac artery dissection tumor diameter \>40 mm;
3. Anatomic criteria

   a)The diameter of the proximal anchoring area (aorta or implanted graft) ranged from 17\~36 mm to ≥25 mm in length; b）Distal anchoring area (aorta or implanted graft): If distal anchoring area is in iliac artery, anchoring area diameter range 7\~25 mm, length ≥15 mm; If the distal anchoring area is in the abdominal aorta, the anchoring area has a diameter of 12\~36 mm and a length of ≥20 mm; c）There is a normal anchoring area at the distal end of the visceral branch vessel. The diameter range of the anchoring area is 6\~13 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 sign the informed consent form, and are willing to complete follow-up as required by the protocol;

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 internal iliac arteries;
3. Patients with a history of acute coronary syndrome within 6 months; Acute coronary syndromes are cardiac acute ischemic syndromes resulting from rupture of an unstable atherosclerotic plaque in the coronary artery or erosion secondary to the formation of 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 stroke within 3 months;
5. Patients with preoperative hepatic and renal dysfunction \[alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 times the normal upper limit; Serum creatinine (Cr) \>150u mol/L\];
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, nylon polymer 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 withdrawn within 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;

Primary outcomes:
measure: The Incidence of Major Adverse Events (MAE) Within 30 Days Postoperative
timeFrame: within 30 days postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospita
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Wei Guo, Professor
role: PRINCIPAL_INVESTIGATOR
References: