BridgeMD
New treatment option for Thoracoabdominal Aortic Aneurysm
Official title Study on Multibranched Stent Graft System in the Treatment of Thoracoabdominal Aortic Aneurysm
ClinicalTrials.gov ID: NCT06478576
What this study is testing
- What it's testing
- The objective of this study is to evaluate the feasibility of multibranched stent graft system for Endovascular Treatment of Thoracoabdominal Aortic Aneurysm(TAAA)
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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...
- 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.
You likely can't join 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;
See the full eligibility 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...
- 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;
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.