Endovascular treatment for aortic arch dissection using a new stent graft system

Guo's Endovascular Aortic Arch Replacement of Aortic Dissection by WeFlow-Tribranch Endoprothesis: a Multicenter Pilot Study(Graft Study)

This study is testing a new stent graft system to see if it can safely help high-risk patients with aortic arch dissection and aneurysm.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Hangzhou Endonom Medtech Co., Ltd. (Industry-sponsored)
• Locations: 4 sites (Beijing, Beijing and 3 other locations)
• Trial ID: NCT05754541 on ClinicalTrials.gov

What this trial studies

This multicenter pilot study aims to evaluate the safety and efficacy of the WeFlow-Tribranch Aortic Arch Stent Graft System in treating high-risk patients with aortic arch dissection and aneurysm. A total of 20 patients aged 18 to 80 will be enrolled, focusing on those with specific vascular conditions suitable for endovascular intervention. The study will assess the outcomes of this innovative approach to managing complex aortic conditions.

Who should consider this trial

Good fit: Ideal candidates include patients aged 18 to 80 diagnosed with subacute or chronic aortic arch dissection or aneurysms who meet specific vascular criteria.

Not a fit: Patients with acute aortic dissection or those who do not meet the vascular criteria for the intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a less invasive option for patients with aortic arch dissection and aneurysm, potentially improving recovery times and outcomes.

How similar studies have performed: While this approach is innovative, similar studies using endovascular techniques for aortic conditions have shown promising results, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Patients aged 18 to 80 years old.
2. The patient was diagnosed with subacute or chronic aortic arch dissection, or Aortic arch aneurysms.
3. Patients showing a suitable vascular condition, including:

   1. Ascending aorta length greater than 50 mm (from the aortic sinusoid junction to the proximal cardiac margin of the innominate artery).
   2. Ascending aorta diameter ≥ 24 mm and ≤ 48 mm;
   3. Proximal anchoring zone length ≥ 30 mm;
   4. Innominate artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm；
   5. Left common carotid artery or left subclavian artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm；
   6. Suitable arterial access for endovascular interventional treatment ;
4. Patients able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the subject him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol.
5. Patients evaluated by at least two vascular surgeons or cardiac surgeons as high surgical risk patients or deemed to have significant surgical contraindications. (The recommended reference criteria are: EuroSCORE score ≥ 6, or CFS score \> 4, or ASA grade 3-4, or there are other high-risk surgical factors that affect the prognosis of the subject, such as patients with a history of open surgery, other high-risk factors judged by a physician team, or patients who refuse open surgery.)

Exclusion Criteria:

1. Patients that have experienced systemic infection during past three months;
2. Neck surgery was performed within three months;
3. Infectious aortic disease、Takayasu arteritis，Marfan syndrome (or other connective tissue diseases );
4. Patients with severe stenosis, calcification, thrombosis or tortuosity of the Brachiocephalic trunk, Left common carotid artery or left subclavian artery;
5. Heart transplant patients;
6. Patients that have suffered MI or stroke during past three months;
7. Patients with Class IV heart function (NYHA classification) or LVEF\<30%
8. Active peptic ulcers or upper gastrointestinal bleeding occurring within the previous three months;
9. Hematological abnormality, defined as follows: Leukopenia (WBC \< 3 × 109/L), acute anemia (Hb \< 90 g/L); thrombocytopenia (PLT count \< 50 × 109/L);
10. Patients with renal insufficiency， serum creatinine \> 150 umol/l (or 3.0 mg/dl) and / or end-stage renal disease requiring renal dialysis shall be determined by the investigator after comprehensive analysis;
11. Subjects with severe liver dysfunction and ALT or AST exceeding 3 times the upper limit of normal; Subjects whose serum total bilirubin (STB) exceeds 2 times the upper limit of normal;
12. Patients with intestinal necrosis and lower limb ischemic necrosis;
13. Paraplegic patients;
14. Patients that are pregnant or breastfeeding;
15. Patients with allergies to contrast agents;
16. Patients with a life expectancy of less than 12 months;
17. Patients currently participating in other drug or device research;
18. Any other disease or abnormality that the investigators believe may hinder endovascular interventional treatment.

Where this trial is running

Beijing, Beijing and 3 other locations

• Chinese PLA Gencral Hosptial — Beijing, Beijing, China (Recruiting)
• Nanjing First Hospital — Nanjing, Jiangsu, China (Recruiting)
• Zhongshan Hospital, Fudan University — Shanghai, Shanghai, China (Not_yet_recruiting)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Not_yet_recruiting)

Study contacts

• Principal investigator: wei Guo — Chinese PLA Gencral Hosptial
• Study coordinator: Wei Guo

Conditions Aortic Aneurysm and Dissection; Stent Graft