Safety and Efficacy of a Multi-branched Thoracoabdominal Stent Graft System for Thoracoabdominal Aortic Aneurysm.

  • STATUS
    Recruiting
  • End date
    Dec 31, 2028
  • participants needed
    73
  • sponsor
    Lifetech Scientific (Shenzhen) Co., Ltd.
Updated on 22 March 2022

Summary

Evaluation of the safety and efficacy of a multi-branched thoracoabdominal stent graft system for thoracoabdominal aortic aneurysm.

Description

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

Details
Condition Thoracoabdominal Aortic Aneurysms
Treatment Multi-Branched Thoracoabdominal Stent Graft System
Clinical Study IdentifierNCT05054985
SponsorLifetech Scientific (Shenzhen) Co., Ltd.
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

18 years old ≤ age ≤ 80 years old
Diagnosed as thoracoabdominal aortic aneurysm (based on modified Crawford classification and 2019 European Guidelines for the Treatment of Aortic aneurysm) and should meet at least one of the following conditions
Maximum diameter of thoracoabdominal aortic aneurysm>50mm
The diameter has increased by more than 5mm in recent 6 months or the by more than 10mm in recent 1 year
anatomical criteria
The proximal anchoring region (aorta or implanted graft) was 17~36 mm in diameter and ≥25 mm in length
Distal anchoring region (aorta or implanted graft): If the distal anchoring region is in the iliac artery, the anchoring region has a diameter range of 7~25 mm and a length of ≥15 mm; If the distal anchoring area is in the abdominal aorta, the diameter of the anchoring area ranges from 12~36mm and the length≥ 20mm
The diameter of the vessel anchoring area of the visceral branch ranges from 6~13 mm and the length ≥15 mm
The diameter of renal artery anchoring area ranges from 4.5~9mm, and the length ≥15 mm
Appropriate iliac, femoral and upper limb artery access
Patients who can understand the purpose of the trial, voluntarily participate and sign
the informed consent, and are willing to complete the follow-up according to
the requirements of the protocol

Exclusion Criteria

Hemodynamically unstable patients with ruptured thoracoabdominal aortic aneurysms
Thoracoabdominal aortic dissection
Mycotic or infectious thoracoabdominal aortic aneurysm
Patients whose systemic or local infection may increase the risk of intravascular graft infection
Superior mesenteric, celiac, or renal artery occlusion
Requiring simultaneous coverage and embolization of bilateral internal iliac arteries
Severe stenosis, calcification, or mural thrombus in the anchoring area of the stent tend to have difficulty in attachment of the stent-graft or affect the patency of the stent
A history of acute coronary syndrome within 6 months; Acute coronary syndrome is defined as an acute ischemic syndrome of the heart resulting from the rupture or erosion of unstable intracoronary atherosclerotic plaques followed by fresh thrombosis, including ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, and unstable angina pectoris
Transient ischemic attack (TIA) or ischemic/haemorrhagic stroke within 3 months
Severe pulmonary insufficiency who cannot tolerate general anaesthesia
Severe coagulation dysfunction
Preoperative liver renal function abnormalities (ALT or AST ≥ 5 times the upper limit of normal value), or serum creatinine ≥ 150 μmol/L
Undergone major surgical or interventionic surgery within 30 days before surgery
A history of allergy to contrast agents, anticoagulants, antiplatelet drugs, stents, and conveyor materials (nitinol, polyester, PTFE, nylon)
Connective tissue diseases such as systemic lupus erythematosus, Marfan's syndrome, Adam's syndrome, or Behcet's disease
Serious vital organ dysfunction or other serious disease
Planning pregnancy, pregnancy, or breastfeeding
takayasu arteritis
Patients who participated in other clinical trials and was not discontinued or withdrawn within the first 3 months of the screening period of this trial
Life expectancy less than 1 year
Patients who, in the judgment of the investigator, are not eligible for endotherapy
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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