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New treatment option for Aortic Arch Aneurysm
Official title Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study)
ClinicalTrials.gov ID: NCT06385379
What this study is testing
- What it's testing
- A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true/pseudo aortic arch aneurysms and ulcers involving 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
- Patients aged 18 to 80 years old;
- Diagnosed with aortic arch lesions requiring intervention, including true aortic arch aneurysms, pseudo-aortic arch aneurysms, and ulcers involving...
- Showing a suitable vascular condition, including:
- Ascending aorta length greater than 50 mm (from the aortic sinusoid junction to the proximal cardiac margin of the innominate artery).
- Ascending aorta diameter ≥ 24 mm and ≤ 48 mm;
You likely can't join if
- Experienced systemic infection during past three months;
- Neck surgery was performed within 3 months;
- Previous endovascular treatment treatment involving the aortic arch was performed;
- Infectious aortic disease, Takayasu arteritis, Marfan syndrome (or other connective tissue diseases );
- Severe stenosis, calcification, thrombosis, or tortuosity of the branch artery to be reconstructed;
- Heart transplant;
See the full eligibility criteria
- Patients aged 18 to 80 years old;
- Diagnosed with aortic arch lesions requiring intervention, including true aortic arch aneurysms, pseudo-aortic arch aneurysms, and ulcers involving the aortic arch;
- Showing a suitable vascular condition, including:
- Ascending aorta length greater than 50 mm (from the aortic sinusoid junction to the proximal cardiac margin of the innominate artery).
- Ascending aorta diameter ≥ 24 mm and ≤ 48 mm;
- Proximal anchoring zone length ≥ 30 mm;
- Branch arteries to be reconstructed were ≤ 24 mm and ≥ 6 mm in diameter and ≥ 20 mm in length;
- Suitable arterial access for endovascular treatment treatment;
- Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the patient him/herself or his or her legal representative, and willing to complete follow-up visits...
- people were assessed as high risk for surgery by at least two investigators or judged to have significant surgical contraindications. Recommended reference criteria were a European system for cardiac operative risk...
- Experienced systemic infection during past three months;
- Neck surgery was performed within 3 months;
- Previous endovascular treatment treatment involving the aortic arch was performed;
- Infectious aortic disease, Takayasu arteritis, Marfan syndrome (or other connective tissue diseases );
- Severe stenosis, calcification, thrombosis, or tortuosity of the branch artery to be reconstructed;
- Heart transplant;
- Suffered Myocardial Infarction or Stroke during past three months;
- Class IV heart function (NYHA classification);
- Active peptic ulcers or upper gastrointestinal bleeding occurring within the previous three months;
- Hematological abnormality, defined as follows: Leukopenia (WBC \< 3 ×109/L), acute anemia (Hb \< 90 g/L), Coagulation disorders, thrombocytopenia (PLT count \< 50 × 109/L);
- Renal insufficiency, creatinine \> 150 umol/L and/or end-stage renal disease requiring renal dialysis;
- Pregnant or breastfeeding;
- Allergies to contrast agents;
- Life expectancy of less than 12 months;
- Participating in another drug or device research;
- Any other disease or abnormality that the investigators believe may hinder endovascular treatment treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Changchun, China
- Changsha, China
- Chengdu, China
- Guangzhou, China
- Harbin, China
- Jinan, China
- Kunming, China
- Nanchang, China
- Nanjing, China
- Qingdao, China
- Shanghai, China
- Shenyang, China
- Xi'an, China
- Xiamen, China
- Zhengzhou, 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, China; Changchun, China; Changsha, China; Chengdu, China; Guangzhou, China; Harbin, China and 10 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.