Study on Multibranched Stent Graft System in the Treatment of Thoracoabdominal Aortic Aneurysm

NCT06478576 | Recruiting

• 1 other identifier: XJ-TAAA-02
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the feasibility of multibranched stent graft system for Endovascular Treatment of Thoracoabdominal Aortic Aneurysm(TAAA)

Conditions

Thoracoabdominal Aortic Aneurysm

Keywords

Lifetech; multibranched stent graft system; Endovascular Treatment

Outcome Measures

Primary Outcomes (2)

• The Incidence of Major Adverse Events (MAE) Within 30 Days Postoperative

  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 postoperative

• The success rate of thoracic and abdominal aortic aneurysm treatment after 12 months of surgery

  Successful treatment of thoracoabdominal aortic aneurysm is a composite endpoint that requires meeting the following indicators at the same time: immediate technical success (immediate technical success refers to the successful delivery of the delivery system to the predetermined position, successful deployment of the system, safe withdrawal of the delivery system from the body, and no type I/III endoleak), and no secondary surgical intervention related to thoracoabdominal aortic aneurysm within 12 months after surgery (secondary surgery caused by aneurysm rupture, continuous enlargement, stent migration, type I/III endoleak, branch vessel stenosis/occlusion).

  Intraoperative and 12 months postoperatively

Secondary Outcomes (10)

• Delivery system-related complications during perioperative period (from surgery to 30 days after surgery)

  perioperative period (from surgery to 30 days after surgery)

• All-cause mortality at 6 months and 12 months postoperatively

  6 months and 12 months postoperatively

• Mortality Rate Related to Thoracoabdominal Aortic Aneurysm at 6 months and 12 months postoperatively

  6 months and 12 months postoperatively

• Incidence of severe adverse events at 6 and 12 months postoperatively

  6 months and 12 months postoperatively

• Device-related adverse events at 6 months and 12 months postoperatively

  6 months and 12 months postoperatively

Study Arms (1)

multibranched stent graft system

EXPERIMENTAL

Endovascular treatment of patients withThoracoabdominal Aortic Aneurysm using multibranched stent graft system

Device: multibranched stent graft system

Interventions

multibranched stent graft system DEVICE

To evaluate the feasibility of multibranched stent graft system for Endovascular Treatment of Thoracoabdominal Aortic Aneurysm(TAAA)

multibranched stent graft system

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 and ≤80 years;
• Patients diagnosed with thoracoabdominal aortic aneurysm (based on the modified Crawford classification and the 2019 European guidelines for the treatment of aortic aneurysms), and should meet at least one of the following conditions:
• Maximum diameter of TAAA \>50 mm,
• Rapid growth of sac \>5 mm in diameter in the most recent 6 months, or rapid growth \>10 mm in diameter within 1 year
• Symptoms related to thoracoabdominal aortic aneurysm, such as clear abdominal pain and back pain.
• Anatomical criteria, including:
• Proximal landing zone 17-36 mm in diameter and ≥25 mm in length
• If distal landing zone in abdominal aorta:Distal landing zone 12-36 mm in diameter and ≥20 mm in length If distal landing zone in iliac artery:Distal landing zone 7-25 mm in diameter and ≥15 mm in length
• Visceral vessel landing zone 6-13 mm in diameter and ≥15 mm in length
• Renal artery landing zone 4.5-9 mm in diameter and ≥15 mm in length
• Patients with Feasible iliofemoral artery and upper patent upper extremity access;
• Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to complete the follow-up according to the requirements of the protocol;

You may not qualify if:

• Ruptured aortic aneurysm in unstable haemodynamic condition;
• Aneurysmal aortic dissection;
• Infected or mycotic aortic aneurysm;
• Patients whose systemic or local infection may increase the risk of intravascular graft infection;
• Patients with occlusion of the superior mesenteric artery, celiac trunk, or renal artery.
• Requiring simultaneous coverage or embolisation for bilateral internal iliac arteries;
• Severe stenosis, calcification, or mural thrombus at stent-graft landing zone;
• Diagnosis of acute coronary syndrome within 6 months; Acute coronary syndrome refers to an acute cardiac ischemia syndrome caused by the rupture or erosion of unstable atherosclerotic plaques in the coronary arteries, which is followed by the formation of fresh thrombus. It includes ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, and unstable angina pectoris.
• Patients with any transient ischemic attack (TIA) or ischemic stroke within 3 months;
• Preoperative liver renal function abnormalities (ALT or AST ≥ 5 times the upper limit of normal value), or serum creatinine ≥ 150 μmol/L;
• Severe pulmonary insufficiency who cannot tolerate general anaesthesia;
• Severe coagulation dysfunction;
• Undergone major surgical or interventionic surgery within 30 days before surgery;
• An allergic history for contrast agents, anticoagulants, antiplatelet drugs, stent graft or materials of delivery system( (referring to nickel-titanium, polyester, PTFE, nylon-based polymer materials);
• Patients with connective tissue diseases, such as systemic lupus erythematosus, Marfan syndrome, Ehlers-Danlos syndrome, or Behcet's disease;

Sponsors & Collaborators

• Lifetech Scientific (Shenzhen) Co., Ltd.: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Wei Guo, Professor

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Xu, PM

CONTACT

15695219339; xuwei@lifetechmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project manager

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 27, 2024
• Study Start: June 1, 2023
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): May 30, 2028
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)