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New treatment option for Thoracoabdominal Aortic Aneurysms
Official title Thoracoabdominal Artery Stent Graft System Exploratory Study
ClinicalTrials.gov ID: NCT06710938
What this study is testing
- What it's testing
- This study is designed as a single-center, prospective, single-arm, open-label, exploratory study. The objective is to evaluate the feasibility of Thoracoabdominal Artery Stent Graft System for endovascular treatment of Thoracoabdominal aortic aneurysms (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 to 80 years old;
- Patients diagnosed with a Thoracoabdominal aortic aneurysm (based on the modified Crawford classification and European Society for Vascular Surgery...
- Maximum diameter of TAAA is \>50 mm;
- TAAA diameter increases by more than 5 mm in the past 6 months or by more than 10 mm in the past 1 year;
- Definite symptoms associated with TAAA, such as abdominal pain and back pain.
You likely can't join if
- Exclusion Criteria (not eligible if any of the criteria is met):
- Patients with ruptured thoracoabdominal aortic aneurysms in unstable hemodynamic condition;
- Patients with thoracoabdominal aortic dissection;
- Patients with infected or mycotic thoracoabdominal aortic aneurysms;
- Patients with systemic or local infections that may increase the risk of endovascular graft infection;
- Patients with occluded superior mesenteric artery, celiac trunk artery, or renal artery;
See the full eligibility criteria
- Age: 18 to 80 years old;
- 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...
- Maximum diameter of TAAA is \>50 mm;
- TAAA diameter increases by more than 5 mm in the past 6 months or by more than 10 mm in the past 1 year;
- Definite symptoms associated with TAAA, such as abdominal pain and back pain.
- Anatomical Criteria
- Proximal landing zone (aorta or implanted graft): the diameter ranges from 17 to 36 mm, and length should be ≥25 mm;
- 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...
- Visceral branch landing zone: the diameter ranges from 6 to 13 mm, and the length should be ≥15 mm;
- Renal artery landing zone: the diameter ranges from 4.5 to 9 mm, and the length should be ≥15 mm;
- Appropriate iliac, femoral, and upper limb arterial access.
- 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;
- Patients do not want to or cannot wait for the approved alternative
- Exclusion Criteria (not eligible if any of the criteria is met):
- Patients with ruptured thoracoabdominal aortic aneurysms in unstable hemodynamic condition;
- Patients with thoracoabdominal aortic dissection;
- Patients with infected or mycotic thoracoabdominal aortic aneurysms;
- Patients with systemic or local infections that may increase the risk of endovascular graft infection;
- Patients with occluded superior mesenteric artery, celiac trunk artery, or renal artery;
- Patients requiring simultaneous coverage or embolization of bilateral internal iliac arteries;
- 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;
- 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...
- Patients with transient ischemic attack (TIA) or ischemic/hemorrhagic stroke within the recent 3 months;
- 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];
- Patients with severe pulmonary insufficiency who cannot tolerate general anesthesia;
The study team makes the final eligibility decision.
Where it's taking place
- Hamburg, Germany
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 Hamburg, Germany. 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.