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

Launched by HANGZHOU ENDONOM MEDTECH CO., LTD. · Feb 28, 2023

Keywords

ClinConnect Summary

The GRAFT Study is a clinical trial designed to explore a new treatment method for patients with serious conditions affecting the aorta, specifically aortic arch dissection and aneurysms. This study aims to see how well a specific endovascular device, called the WeFlow-Tribranch Endoprothesis, works in high-risk patients. If you are between 18 and 80 years old and have been diagnosed with aortic arch dissection or aneurysms, you may be eligible to participate. To qualify, your doctors must also confirm that you are at high risk for traditional surgery due to various health factors.

Participants in this trial will receive the new endovascular treatment and will be monitored to assess its effectiveness and safety. The study is currently recruiting participants, and individuals will be asked to provide informed consent, meaning you'll have to agree to take part after understanding the study's purpose and procedures. It's important to know that certain health conditions may exclude you from participating, such as recent infections or severe heart and kidney issues. If you decide to join, your involvement will contribute to valuable research aimed at improving treatment options for patients with aortic conditions.

Gender

ALL

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.