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

Primary Purpose

Thoracoabdominal; Aortic, Aneurysm, Dissecting

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Thoracoabdominal aortic stent system
Sponsored by
Lifetech Scientific (Shenzhen) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracoabdominal; Aortic, Aneurysm, Dissecting focused on measuring Thoracoabdominal aortic stent system, thoracoabdominal aortic dissecting aneurysm, G-Branch

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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; Exclusion Criteria: Patients with severe hematoma in aortic wall in proximal anchoring area of stent Patients requiring simultaneous coverage and embolization of bilateral internal iliac arteries; 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. Patients with a transient ischemic attack (TIA) or ischemic/hemorrhagic stroke within 3 months; 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]; Patients with severe pulmonary insufficiency who cannot tolerate general anesthesia; Patients with severe coagulopathy; Patients with a history of hypersensitivity to contrast agents, anticoagulants, antiplatelet agents, stent delivery devices (i.e., nitinol, polyester, PTFE, nylon polymer materials); Patients with connective tissue diseases such as systemic lupus erythematosus, Marfan syndrome, Egyptian syndrome, or Behcet's disease; Patients with arteritis; Patients with significant organ dysfunction or other serious disease; Women with planned pregnancy, pregnancy stage , or lactation; 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. Patients with a life expectancy of not more than 1 year; Patients judged by the investigator to be unsuitable for endovascular treatment;

Sites / Locations

  • Chinese PLA General HospitaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention arm

Arm Description

Outcomes

Primary Outcome Measures

The Incidence of Major Adverse Events (MAE) Within 30 Days Postoperative
Major Adverse events (MAE) are defined as death related to thoracic and abdominal aortic dissecting aneurysms, stroke, permanent paraplegia, kidney failure, intestinal necrosis, myocardial infarction, respiratory failure, and liver failure.

Secondary Outcome Measures

Full Information

First Posted
March 26, 2023
Last Updated
March 26, 2023
Sponsor
Lifetech Scientific (Shenzhen) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05803564
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lifetech Scientific (Shenzhen) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracoabdominal; Aortic, Aneurysm, Dissecting
Keywords
Thoracoabdominal aortic stent system, thoracoabdominal aortic dissecting aneurysm, G-Branch

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Thoracoabdominal aortic stent system
Intervention Description
Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with thoracoabdominal aortic stent system.
Primary Outcome Measure Information:
Title
The Incidence of Major Adverse Events (MAE) Within 30 Days Postoperative
Description
Major Adverse events (MAE) are defined as death related to thoracic and abdominal aortic dissecting aneurysms, stroke, permanent paraplegia, kidney failure, intestinal necrosis, myocardial infarction, respiratory failure, and liver failure.
Time Frame
within 30 days postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: Patients with severe hematoma in aortic wall in proximal anchoring area of stent Patients requiring simultaneous coverage and embolization of bilateral internal iliac arteries; 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. Patients with a transient ischemic attack (TIA) or ischemic/hemorrhagic stroke within 3 months; 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]; Patients with severe pulmonary insufficiency who cannot tolerate general anesthesia; Patients with severe coagulopathy; Patients with a history of hypersensitivity to contrast agents, anticoagulants, antiplatelet agents, stent delivery devices (i.e., nitinol, polyester, PTFE, nylon polymer materials); Patients with connective tissue diseases such as systemic lupus erythematosus, Marfan syndrome, Egyptian syndrome, or Behcet's disease; Patients with arteritis; Patients with significant organ dysfunction or other serious disease; Women with planned pregnancy, pregnancy stage , or lactation; 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. Patients with a life expectancy of not more than 1 year; Patients judged by the investigator to be unsuitable for endovascular treatment;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Xu
Phone
15695219339
Ext
86
Email
xuwei@lifetechmed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Guo, Professor
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospita
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Guo

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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