Guo's Visceral Arteries Reconstruction: First in Man Study

Not Applicable

Completed

• Conditions: Pararenal Aortic Aneurysm; Thoracoabdominal Aortic Aneurysm
• Interventions: Device: Thoracoabdominal aortic stent system

• Registration Number: NCT04731636
• Lead Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.

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.

Study Timeline

• Study Start: 2019-10-17
• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-01-26
• Study First Posted: 2021-02-01
• Primary Completion: 2022-03-10
• Study Completion: 2022-03-22
• Results First Submitted: 2022-12-07
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-07
• Last Update Submitted: 2024-07-07
• Results First Posted: 2024-07-10
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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;

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
G-Branch Thoracoabdominal Aortic Stent System	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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Major Adverse Events (MAE) Within 30 Days Postoperative	within 30-days postoperative	Major Adverse events (MAE) are defined as all-cause death, liver failure, intestinal necrosis, splenic infarction, renal infarction, renal failure, cerebral infarction, paraplegia, myocardial infarction, and respiratory failure.

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China