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New treatment option for Aortic Arch Aneurysm
Official title Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases
ClinicalTrials.gov ID: NCT06520774
What this study is testing
- What it's testing
- The objective of the study is to evaluate the safety and efficacy of the Lifetech Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases
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 who are aged 18 to 80 years inclusive；
- Patients diagnosed with aortic arch aneurysms or penetrating ulcers that require intervention, and for whom the proximal end of the stent needs to be...
- Anatomical criteria, including:
- Ascending aorta length is greater than or equal to 50 mm (distance from aortic sinus to anterior edge of innominate artery);
- The diameter range of the anchoring area at the proximal end of the main body is between 25-45 mm and the length is greater than or equal to 30 mm;
You likely can't join if
- Patients either with ruptured or infected aneurysms;
- Patients with aortic dissection;
- Patients with general or local infections that may increase the risk of endovascular graft infection;
- Patients with severe stenosis, calcification, or mural thrombus in the stent anchoring area, which is likely to impede stent-graft adherence or...
- Previous endovascular intervention involving the aortic arch;
- Underwent open or endovascular surgery for abdominal aorta within the past 3 months;
See the full eligibility criteria
- Patients who are aged 18 to 80 years inclusive；
- Patients diagnosed with aortic arch aneurysms or penetrating ulcers that require intervention, and for whom the proximal end of the stent needs to be anchored in the Z0 zone;
- Anatomical criteria, including:
- Ascending aorta length is greater than or equal to 50 mm (distance from aortic sinus to anterior edge of innominate artery);
- The diameter range of the anchoring area at the proximal end of the main body is between 25-45 mm and the length is greater than or equal to 30 mm;
- The diameter of the anchored area of supra-arch branch vessels (innominate artery, left common carotid artery, left subclavian artery) is between 5-18 mm, distal anchorage length is greater than or equal to 15 mm;
- Distance between the anterior edge of the innominate artery to the posterior edge of the left subclavian artery is less than or equal to 80 mm;
- Have a suitable iliac, femoral, and superior arch arterial access;
- At least two researchers should assess that the subject is a high-risk patient for surgical treatment or has significant contraindications to surgery. It is recommended to refer to the following criteria: a score of ≥6...
- Patients who understand the purpose of the study, volunteer to participate and sign the informed consent form, and are willing to complete follow-up visits as required by the protocol.
- Patients either with ruptured or infected aneurysms;
- Patients with aortic dissection;
- Patients with general or local infections that may increase the risk of endovascular graft infection;
- Patients with severe stenosis, calcification, or mural thrombus in the stent anchoring area, which is likely to impede stent-graft adherence or affect stent patency;
- Previous endovascular intervention involving the aortic arch;
- Underwent open or endovascular surgery for abdominal aorta within the past 3 months;
- Patients with a history of stroke within the past 3 months (excluding TIA);
- Patients with aneurysms involving the distal descending aorta and requiring reconstruction of important visceral branch vessels within the abdomen;
- Patients with a history of myocardial infarction within the past 3 months;
- Patients with congestive heart failure - NYHA Class IV;
- Patients allergic to contrast agents, stent and delivery system materials (such as nitinol, polyester, PTFE, nylon polymer materials);
- Patients with contraindications to anticoagulant or antiplatelet drugs;
- Patients unable to tolerate general anesthesia;
- Patients with abnormal liver and kidney function before surgery (ALT or AST more than 5 times the upper limit of normal; serum creatinine (Cr) \>150umol/L);
- Patients with connective tissue diseases, such as Marfan syndrome, Ehlers-Danlos syndrome, or Behcet's disease;
- Patients with arteritis;
- Patients with a life expectancy of less than 1 year;
- Women who are planning to conceive, pregnant or breastfeeding;
- Patients deemed by the investigator as unsuitable for endovascular treatment;
- Patients who have participated in other clinical studies and have not withdrawn or been excluded within the 3 months prior to the screening period of this study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Changsha, China
- Chengdu, China
- Fuzhou, China
- Hanzhou, China
- Kunming, China
- Nanjing, China
- Shanghai, China
- Shenzhen, China
- Wuhan, China
- Xiamen, China
- Zhengzhou, China
- Freiburg im Breisgau, 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 Beijing, China; Changsha, China; Chengdu, China; Fuzhou, China; Hanzhou, China; Kunming, China and 7 more location(s). 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.