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

Thoracoabdominal Aortic Aneurysms Clinical Trial

Official title:

Guo's Renovisceral Artery Reconstruction-1: a Prospective, Multicenter, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of a Multi-branched Stent Graft System for Thoracoabdominal Aortic Aneurysm (GUARANTEE Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05054985
• Other study ID #: XJ-TAAA-01
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2021
• Est. completion date: December 31, 2028

Study information

• Verified date: January 2024
• Source: Lifetech Scientific (Shenzhen) Co., Ltd.
• Contact: Wei Guo, Professor
• Phone: 13910758706
• Email: pla301dml[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 73
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 18 years old = age = 80 years old;

2. 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;

1. Maximum diameter of thoracoabdominal aortic aneurysm>50mm;

2. The diameter has increased by more than 5mm in recent 6 months or the by more than 10mm in recent 1 year;

3. anatomical criteria

1. The proximal anchoring region (aorta or implanted graft) was 17~36 mm in diameter and =25 mm in length;

2. 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;

3. The diameter of the vessel anchoring area of the visceral branch ranges from 6~13 mm and the length =15 mm;

4. The diameter of renal artery anchoring area ranges from 4.5~9mm, and the length =15 mm;

5. Appropriate iliac, femoral and upper limb artery access;

4. 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:

1. Hemodynamically unstable patients with ruptured thoracoabdominal aortic aneurysms;

2. Thoracoabdominal aortic dissection;

3. Mycotic or infectious thoracoabdominal aortic aneurysm;

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

5. Superior mesenteric, celiac, or renal artery occlusion;

6. Requiring simultaneous coverage and embolization of bilateral internal iliac arteries;

7. 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;

8. 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.

9. Transient ischemic attack (TIA) or ischemic/haemorrhagic stroke within 3 months;

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

11. Severe pulmonary insufficiency who cannot tolerate general anaesthesia;

12. Severe coagulation dysfunction;

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

14. A history of allergy to contrast agents, anticoagulants, antiplatelet drugs, stents, and conveyor materials (nitinol, polyester, PTFE, nylon);

15. Connective tissue diseases such as systemic lupus erythematosus, Marfan's syndrome, Adam's syndrome, or Behcet's disease;

16. takayasu arteritis;

17. Serious vital organ dysfunction or other serious disease;

18. Planning pregnancy, pregnancy, or breastfeeding;

19. 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.

20. Life expectancy less than 1 year;

21. Patients who, in the judgment of the investigator, are not eligible for endotherapy.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Aortic Aneurysm, Thoracoabdominal
• Thoracoabdominal Aortic Aneurysms

Intervention

Device:
• Multi-Branched Thoracoabdominal Stent Graft System
Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with multi-branched thoracoabdominal stent graft system .

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Lifetech Scientific (Shenzhen) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary safety endpoint: The incidence of Major Adverse events (MAE) within 30 days after procedure.	Major Adverse Event (MAE) was defined as all-cause death, liver failure, intestinal necrosis, kidney failure, stroke, permanent paraplegia, myocardial infarction, and respiratory failure.	Within 30 days after procedure
Primary	Primary efficacy endpoint: Success rate of thoracoabdominal aortic aneurysm treatment 12 months after procedure.	Successful treatment of thoracoabdominal aortic aneurysm is a composite index that needs to meet the following indicators at the same time: Immediate technical success (immediate technical success refers to the successful delivery system to a predetermined location, the successful deployment of the system and the safe withdrawal of the delivery system from the body and no type I/III endoleak), no secondary surgical intervention related to thoracoabdominal aortic aneurysms 12 months after procedure (due to aneurysm rupture, continuous enlargement, stent displacement, type I/III endoleak, branch stenosis/ Second surgery caused by occlusion) .	12 months after procedure.
Secondary	aneurysmal enlargement at 6 and 12 months postoperatively	aneurysmal enlargement defined as a maximum aortic diameter increase of > 5 mm relative to preoperative computed tomography angiography (CTA)	6 and 12 months postoperatively
Secondary	type I/III endoleak at 6 and 12 months postoperatively		6 and 12 months postoperatively
Secondary	stent graft migration at 6 and 12 months postoperatively		6 and 12 months postoperatively
Secondary	renovisceral artery patency rate at 6 and 12 months postoperatively		6 and 12 months postoperatively
Secondary	reintervention secondary to TAAA progression at 6 months, 12 months, and 2-5 years postoperatively.		6 months, 12 months, and 2-5 years postoperatively.
Secondary	delivery system-related complications during the procedure and within 30 days postoperatively, including conversion to open surgery, and any hemorrhage, hematoma, or pseudoaneurysm of the arterial access		during the procedure and within 30 days postoperatively
Secondary	all-cause mortality at 6 months, 12 months, and 2-5 years postoperatively		6 months, 12 months, and 2-5 years postoperatively
Secondary	TAAA-related mortality at 6 months, 12 months, and 2-5 years postoperatively		6 months, 12 months, and 2-5 years postoperatively
Secondary	device-related adverse events at 6 months, 12 months, and 2-5 years postoperatively		6 months, 12 months, and 2-5 years postoperatively
Secondary	severe adverse events resulting in death or serious deterioration of health at 6 months, 12 months, and 2-5 years postoperatively		6 months, 12 months, and 2-5 years postoperatively