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New treatment option for Thoracoabdominal; Aortic, Aneurysm, Dissecting
Official title Thoracoabdominal Aortic Stent System for Endovascular Treatment of Thoracoabdominal Aortic Dissecting Aneurysm.
ClinicalTrials.gov ID: NCT05803564
What this study is testing
- What it's testing
- A First in man study to evaluate the safety and efficacy of thoracoabdominal aortic stent system for endovascular treatment of thoracoabdominal aortic dissecting aneurysm.
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
- Patients aged greater than 18 years old and less than 80 years old;
- Patients diagnosed with thoraco-abdominal aortic dissecting aneurysm and at least one of the following conditions should be met: a)Maximum aneurysm...
- Anatomic criteria a)The diameter of the proximal anchoring area (aorta or implanted graft) ranged from 17\~36 mm to ≥25 mm in length; b）Distal...
- Patients who understand the purpose of the trial, volunteer to participate and sign the informed consent form, and are willing to complete follow-up...
You likely can't join if
- Patients with severe hematoma in aortic wall in proximal anchoring area of stent
- Patients requiring simultaneous coverage and embolization of bilateral internal iliac arteries;
- Patients with a history of acute coronary syndrome within 6 months; Acute coronary syndromes are cardiac acute ischemic syndromes resulting from...
- Patients with a transient ischemic attack (TIA) or ischemic/hemorrhagic stroke within 3 months;
- Patients with preoperative hepatic and renal dysfunction [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 times the normal...
- Patients with severe pulmonary insufficiency who cannot tolerate general anesthesia;
See the full eligibility criteria
- Patients aged greater than 18 years old and less than 80 years old;
- Patients diagnosed with thoraco-abdominal aortic dissecting aneurysm and at least one of the following conditions should be met: a)Maximum aneurysm diameter \>50 mm; b）Increase in diameter by more than 5 mm in recent 6...
- Anatomic criteria a)The diameter of the proximal anchoring area (aorta or implanted graft) ranged from 17\~36 mm to ≥25 mm in length; b）Distal anchoring area (aorta or implanted graft): If distal anchoring area is in...
- Patients who understand the purpose of the trial, volunteer to participate and sign the informed consent form, and are willing to complete follow-up as required by the protocol;
- Patients with severe hematoma in aortic wall in proximal anchoring area of stent
- Patients requiring simultaneous coverage and embolization of bilateral internal iliac arteries;
- Patients with a history of acute coronary syndrome within 6 months; Acute coronary syndromes are cardiac acute ischemic syndromes resulting from rupture of an unstable atherosclerotic plaque in the coronary artery or...
- Patients with a transient ischemic attack (TIA) or ischemic/hemorrhagic stroke within 3 months;
- Patients with preoperative hepatic and renal dysfunction [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 times the normal upper limit; Serum creatinine (Cr) \>150u mol/L];
- Patients with severe pulmonary insufficiency who cannot tolerate general anesthesia;
- Patients with severe coagulopathy;
- Patients with a history of hypersensitivity to contrast agents, anticoagulants, antiplatelet agents, stent delivery devices (i.e., nitinol, polyester, PTFE, nylon polymer materials);
- Patients with connective tissue diseases such as systemic lupus erythematosus, Marfan syndrome, Egyptian syndrome, or Behcet's disease;
- Patients with arteritis;
- Patients with significant organ dysfunction or other serious disease;
- Women with planned pregnancy, pregnancy stage , or lactation;
- The patient participated in another clinical trial and was not out or withdrawn within the first 3 months of the screening period of this trial.
- Patients with a life expectancy of not more than 1 year;
- Patients judged by the investigator to be unsuitable for endovascular treatment;
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, 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, Beijing Municipality, 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.