Thoracoabdominal Artery Stent Graft System Exploratory Study

Launched by LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. · Nov 27, 2024

Keywords

ClinConnect Summary

The Thoracoabdominal Artery Stent Graft System Exploratory Study is a clinical trial aimed at exploring a new treatment option for patients with thoracoabdominal aortic aneurysms (TAAA), which are enlarged areas in the aorta that can be dangerous if they grow too large or rupture. This study will take place at a single medical center and will focus on whether the Thoracoabdominal Artery Stent Graft System is a feasible and effective way to treat TAAA.

To be eligible for this study, participants must be between 18 and 80 years old and diagnosed with TAAA that meets certain criteria, such as having a diameter larger than 50 mm or showing significant growth recently. Participants will need to understand the purpose of the study and agree to take part by signing a consent form. This trial is not yet recruiting participants, but if you qualify, you can expect to receive the experimental stent graft treatment and will be monitored closely throughout the study to track your progress. It's important to note that individuals with certain health conditions, like recent heart problems or infections, will not be eligible for this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age: 18 to 80 years old;
• 2. Patients diagnosed with a Thoracoabdominal aortic aneurysm (based on the modified Crawford classification and European Society for Vascular Surgery (ESVS) 2019 Clinical Practice Guidelines on the Management of Abdominal Aorto-iliac Artery Aneurysms), and should meet at least ONE of the following conditions:
• • 1. Maximum diameter of TAAA is \>50 mm;
• • 2. TAAA diameter increases by more than 5 mm in the past 6 months or by more than 10 mm in the past 1 year;
• • 3. Definite symptoms associated with TAAA, such as abdominal pain and back pain.
• • 3. Anatomical Criteria
• • 1. Proximal landing zone (aorta or implanted graft): the diameter ranges from 17 to 36 mm, and length should be ≥25 mm;
• • 2. Distal landing zone (aorta or implanted graft): If distal landing zone is in iliac artery, distal landing zone diameter ranges from 7 to 25 mm, and length should be ≥15 mm; If the distal landing zone is in the abdominal aorta, distal landing zone diameter ranges from 12 to 36 mm, and length should be ≥20 mm.
• • 3. Visceral branch landing zone: the diameter ranges from 6 to 13 mm, and the length should be ≥15 mm;
• • 4. Renal artery landing zone: the diameter ranges from 4.5 to 9 mm, and the length should be ≥15 mm;
• • 5. Appropriate iliac, femoral, and upper limb arterial access.
• • 4. Patients who understand the purpose of the study, volunteer to participate and sign the informed consent form, and are willing to complete follow-up as required by the protocol;
• • 5. Patients do not want to or cannot wait for the approved alternative
• Exclusion Criteria:
• Exclusion Criteria (not eligible if any of the criteria is met):
• • 1. Patients with ruptured thoracoabdominal aortic aneurysms in unstable hemodynamic condition;
• • 2. Patients with thoracoabdominal aortic dissection;
• • 3. Patients with infected or mycotic thoracoabdominal aortic aneurysms;
• • 4. Patients with systemic or local infections that may increase the risk of endovascular graft infection;
• • 5. Patients with occluded superior mesenteric artery, celiac trunk artery, or renal artery;
• • 6. Patients requiring simultaneous coverage or embolization of bilateral internal iliac arteries;
• • 7. Patients with severe stenosis, calcification or mural thrombus at stent-graft landing zone, and this situation leads to difficulty in adhering the covered stent or affecting the patency of the stent;
• • 8. Patients with a history of acute coronary syndrome within the recent 6 months; Acute coronary syndrome refers to acute cardiac ischemic syndrome caused by rupture or erosion of unstable atherosclerotic plaques in the coronary artery and fresh thrombosis, including ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI) and unstable angina pectoris.
• • 9. Patients with transient ischemic attack (TIA) or ischemic/hemorrhagic stroke within the recent 3 months;
• • 10. Patients with abnormal liver and kidney function before operation \[alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 times the upper limit of normal value; Serum creatinine (Cr) \>150umol/L\];
• • 11. Patients with severe pulmonary insufficiency who cannot tolerate general anesthesia;