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

Official title

GUo's Renovisceral Artery Reconstruction-2: a Prospective,Single Center,Single-arm Clinical Trial to Evaluate the Safety and Efficacy of a multibRANched sTEnt Graft systEm for Thoracoabdominal Aortic Aneurysm

Overview

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

Detailed description

The physician shall strictly follow the clinical study protocol and shall not deviate from or substantially change the protocol. However, in case of emergency such as immediate risk to the subjects, which needs tobe eliminated immediately, it may be reported in written form afterwards. During the course of the study,documents such as amendments to the clinical study protocol and informed consent, requests for deviation,and resumption of the suspended clinical study shall be subject to the written approval of the Ethics Committee

Interventions

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

Primary outcome measures

• The Incidence of Major Adverse Events (MAE) Within 30 Days Postoperative [Time frame: within 30 days postoperative]
• The success rate of thoracic and abdominal aortic aneurysm treatment after 12 months of surgery [Time frame: Intraoperative and 12 months postoperatively]

Secondary outcome measures (10)

• Delivery system-related complications during perioperative period (from surgery to 30 days after surgery) [Time frame: perioperative period (from surgery to 30 days after surgery)]
• All-cause mortality at 6 months and 12 months postoperatively [Time frame: 6 months and 12 months postoperatively]
• Mortality Rate Related to Thoracoabdominal Aortic Aneurysm at 6 months and 12 months postoperatively [Time frame: 6 months and 12 months postoperatively]
• Incidence of severe adverse events at 6 and 12 months postoperatively [Time frame: 6 months and 12 months postoperatively]
• Device-related adverse events at 6 months and 12 months postoperatively [Time frame: 6 months and 12 months postoperatively]
• Incidence rate of aneurysmal enlargement at 6 and 12 months postoperatively [Time frame: 6 and 12 months postoperatively]
• Incidence rate of Type I/III endoleak at 6 and 12 months postoperatively [Time frame: 6 and 12 months postoperatively]
• Incidence rate of Stent graft migration at 6 and 12 months postoperatively [Time frame: 6 and 12 months postoperatively]
• The patency rate of the renovisceral artery at 6 and 12 months postoperatively [Time frame: 6 and 12 months postoperatively]
• Incidence of secondary surgical interventions related to the Thoracoabdominal Aortic Aneurysm at 6 and 12 months postoperatively [Time frame: 6 and 12 months postoperatively]

Eligibility criteria

Inclusion criteria

• 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;

Exclusion criteria

• 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;
• Patients with takayasu arteritis;
• Patients with serious vital organ dysfunction or other serious disease;
• Planning pregnancy, pregnancy, or breastfeeding;
• 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 ;
• Life expectancy less than 1 year;
• Patients who are not appropriate for endovascular repair based on the investigators' clinical judgement.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

China · 1 center

• Chinese PLA General Hospital — Beijing

Identifiers

NCT: NCT06478576 · XJ-TAAA-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗