Clinical Application of a New Technique of Thoracoabdominal Aortic Stent System for Endovascular Treatment of Thoracoabdominal Aortic Dissecting Aneurysm.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Patients aged greater than 18 years old and less than 80 years old;

• 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;

• 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.

• 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;

Locations
Other Locations
China
Chinese PLA General Hospita
RECRUITING
Beijing
Contact Information
Primary
Wei Xu
xuwei@lifetechmed.com
15695219339
Time Frame
Start Date: 2021-10-01
Estimated Completion Date: 2027-10-01
Participants
Target number of participants: 46
Treatments
Experimental: Intervention arm
Endovascular treatment of patients withThoracoabdominal Aortic Aneurysm using multibranched stent graft system
Sponsors
Leads: Lifetech Scientific (Shenzhen) Co., Ltd.

This content was sourced from clinicaltrials.gov