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New treatment option for Aortic Dissection
Official title Study on the Aortic Arch Single Branch Stent Graft System
ClinicalTrials.gov ID: NCT06915545
What this study is testing
- What it's testing
- The objective of the study is to evaluate the Safety and Efficacy of Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch
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 between 18 and 80 years, gender unrestricted.
- Patients are diagnosed with Stanford Type B aortic dissection and need revascularization of the left subclavian artery.
- Anatomical criteria:
- The diameter range of the proximal aortic landing zone is 20-42 mm.
- The length of the proximal aortic landing zone (the distance from the posterior edge of the left common carotid artery orifice to the first intimal...
You likely can't join if
- Previously undergone endovascular treatment treatment involving the aortic arch, or having a history of aortic surgical repair surgery, which affects...
- Patients with severe stenosis, calcification, or mural thrombus in the stent anchoring area pose challenges. Such conditions may easily prevent...
- Infectious aortic diseases, giant cell arteritis, Marfan syndrome (or other hereditary connective tissue diseases).
- Patients with systemic or local infections that may increase the risk of infection of the endovascular graft.
- Patients who have received abdominal aortic surgical or endovascular treatment surgery within the past 3 months.
- Patients who have had a stroke attack (excluding transient ischemic attack, TIA) or myocardial infarction within the past 3 months.
See the full eligibility criteria
- Age between 18 and 80 years, gender unrestricted.
- Patients are diagnosed with Stanford Type B aortic dissection and need revascularization of the left subclavian artery.
- Anatomical criteria:
- The diameter range of the proximal aortic landing zone is 20-42 mm.
- The length of the proximal aortic landing zone (the distance from the posterior edge of the left common carotid artery orifice to the first intimal tear) is ≥15 mm.
- The distance between the left common carotid artery and the left subclavian artery is ≥5 mm.
- The length of the left subclavian artery landing zone is ≥25 mm, and the diameter range of the landing zone is 5-15 mm.
- Suitable access to the femoral artery, iliac artery, and upper limb artery.
- Patients understand the purpose of the study, volunteer to participate, and are willing to complete follow - up visits as required by the protocol.
- Previously undergone endovascular treatment treatment involving the aortic arch, or having a history of aortic surgical repair surgery, which affects the implantation and evaluation of the single branched covered stent...
- Patients with severe stenosis, calcification, or mural thrombus in the stent anchoring area pose challenges. Such conditions may easily prevent covered stents from adhering to the vessel wall or affect stent patency.
- Infectious aortic diseases, giant cell arteritis, Marfan syndrome (or other hereditary connective tissue diseases).
- Patients with systemic or local infections that may increase the risk of infection of the endovascular graft.
- Patients who have received abdominal aortic surgical or endovascular treatment surgery within the past 3 months.
- Patients who have had a stroke attack (excluding transient ischemic attack, TIA) or myocardial infarction within the past 3 months.
- Patients known to be allergic to contrast agents, stent materials, and delivery device materials (referring to nitinol, Dacron, PTFE, nylon polymer materials).
- Patients known to have contraindications to anticoagulant and antiplatelet drugs.
- Patients intolerant to general anesthesia.
- Patients with severe abnormalities in liver, kidney, and cardiac function before the operation [people with a serum creatinine level exceeding 150 μmol/L; people with alanine aminotransferase (ALT) or aspartate...
- Patients whose expected lifespan is shorter than 1 year.
- Female patients who are planning to conceive, are currently pregnant, or are breastfeeding.
- Patients whom, in the researcher's judgment, are not appropriate candidates for endovascular treatment.
- Patients who have been involved in other clinical studies and have not withdrawn from or exited the respective study groups within the three months preceding the screening period of this present study.
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, 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 Changsha, 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.