Guo's Visceral Arteries Reconstruction: First in Man Study

NCT ID: NCT04731636

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-17
• Study Completion Date: 2022-03-22

Brief Summary

A First in man study to evaluate the safety and efficacy of thoracoabdominal aortic stent system for thoracoabdominal aortic aneurysms and pararenal abdominal aortic aneurysm.

Detailed Description

The study is mainly for patients with Crawford type I-V thoracoabdominal aortic aneurysms and pararenal abdominal aortic 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.

Conditions

Thoracoabdominal Aortic Aneurysm; Pararenal Aortic Aneurysm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

G-Branch Thoracoabdominal Aortic Stent System

Patients with Crawford type I-V thoracoabdominal aortic aneurysms and Pararenal abdominal aortic aneurysm, and passed the screening and signed the Informed Consent Form

Group Type: EXPERIMENTAL

Thoracoabdominal aortic stent system

Intervention Type: DEVICE

Patients who meet all inclusion criteria and don't meet any exclusion criteria were implanted with thoracoabdominal aortic stent system.

Interventions

Thoracoabdominal aortic stent system

Patients who meet all inclusion criteria and don't meet any exclusion criteria were implanted with thoracoabdominal aortic stent system.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 and ≤80 years;

2. Patients diagnosed with type Crawford I-V thoracoabdominal aortic aneurysmsa and pararenal abdominal aortic aneurysm, and should meet at least one of the following conditions:

1. The maximum diameter of thoracoabdominal aortic aneurysms and pararenal abdorminal aortic aneurysm > 50 mm;

2. Rapid growth of sac >5 mm in diameter in the most recent 6 months;

3. Definite symptoms of abdominal pain and low back pain associated with thoracicabdominal aortic aneurysms.

3. Patients with four indispensable reno-visceral arteries including superior mesenteric artery, celiac trunk and bilaterial renal arteries.

4. Proximal landing zone 20-36 mm in diameter;

5. Proximal landing zone ≥25 mm in length;

6. If distal landing zone in abdominal aorta, distal landing zone should be 12-36mm in diameter and ≥15 mm in length.

7. The visceral vascular branches landing zone 6~13 mm in diameter and ≥15 mm in length;

8. The renal artery landing zone 4.5~9 mm in diameter and ≥15 mm in length;

9. Patients who using the abdominal aortic bifurcation stent graft system should also meet the following criteria:

1. The ilac artery landing zone 7 ~25 mm in diameter;

2. The ilac artery landing zone ≥15 mm in length;

10. Patients with appropriate iliacofemoral access and at least one patent upper extremity access;

11. Patients who can understand the purpose of the trial, volunntarily participate and sign the informed consent form, and are willing to complete the follow-up according to the requirements of the protocol;

Exclusion Criteria

1. Ruptured aortic aneurysm in unstable haemodynamic condition;

2. Aneurysmal aortic dissection;

3. Infected or mycotic aortic aneurysm;

4. Requiring simultaneous coverage or embolisation for bilateral internal iliac arteries;

5. Severe stenosis, calcification, or mural thrombus at stent-graft landing zone;

6. Diagnosis of acute coronary syndrome within 6 months;

7. Patients with any transient ischemic attack (TIA) or ischemic stroke within 3 months;

8. An allergic history for contrast agents, anticoagulants, antiplatelet drugs, stent graft or materials of delivery system；

9. Patients with connective tissue diseases;

10. Patients with takayasu arteritis;

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

12. Preoperative liver renal function abnormalities (ALT or AST ≥ 5 times the upper limit of normal value), or serum creatinine ≥ 150 μmol/L;

13. Severe pulmonary insufficiency who cannot tolerate general anaesthesia;

14. Severe coagulation dysfunction;

15. Undergone major surgical or interventionic surgery within 30 days before surgery;

16. Patients whose systemic or local infection may increase the risk of intravascular graft infection;

17. Planning pregnancy, pregnancy, or breastfeeding;

18. The patient participated in other clinical trials or not completed or withdrawn from other clinical trials within the last 3 months at the time of screening period ;

19. Life expectancy less than 1 year;

20. Patients not appropriate for endovascular repair based on the investigators' clinical judgement.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lifetech Scientific (Shenzhen) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

XuWei

Project manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wei Guo, Professor

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Locations

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

TAAA-FIM-001

Identifier Type: -

Identifier Source: org_study_id