UnknownNot Applicable

Percutaneous Endovascular Arch Repair Trial (PEART) Study

China24 participantsStarted 2023-04-28

Plain-language summary

This study is the feasible study on a new technique of ZIPPER aortic arch stentgraft system

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patients aged 18 to 80 years old
✓. Patients diagnosed with aortic arch disease requiring intervention, including non-A-non-B aortic dissection, or residual dissection after type A ascending aortic repair; aortic arch aneurysms.
✓. Patients with suitable vascular conditions, including:
✓. Ascending aorta (including surgical graft) length greater than 30 mm (from the aortic sinusoid junction to the proximal cardiac margin of the innominate artery).
✓. Proximal anchoring zone diameter ≥ 24 mm and ≤ 47 mm;
✓. Proximal anchoring zone length ≥ 20 mm;
✓. Innominate artery, left common carotid artery and left subclavian artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm；
✓. Suitable arterial access for endovascular interventional treatment;

✕. Previously received open surgery or endovascular intervention for descending aorta or abdominal aorta;
✕. Infectious aortic disease, takayasu arteritis, Marfan syndrome (or other connective tissue diseases );
✕. Patients that have experienced systemic infection within past three months;
✕. Neck surgery was performed within past three months;
✕. Patients with severe stenosis, calcification, thrombosis or tortuosity in the brachiocephalic trunk, left common carotid artery or left subclavian artery;
✕. Patients with intestinal necrosis and lower limb ischemic necrosis;
✕. Paraplegic patients;
✕. Heart transplant patients;

Freedom from major device/procedure-related adverse events within 30 days post-operation.

Timeframe: 30 days after intervention

NCT IDNCT05872282

SponsorHangzhou Endonom Medtech Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-28

Wayne W. Zhang

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patients aged 18 to 80 years old
✓. Patients diagnosed with aortic arch disease requiring intervention, including non-A-non-B aortic dissection, or residual dissection after type A ascending aortic repair; aortic arch aneurysms.
✓. Patients with suitable vascular conditions, including:
✓. Ascending aorta (including surgical graft) length greater than 30 mm (from the aortic sinusoid junction to the proximal cardiac margin of the innominate artery).
✓. Proximal anchoring zone diameter ≥ 24 mm and ≤ 47 mm;
✓. Proximal anchoring zone length ≥ 20 mm;
✓. Innominate artery, left common carotid artery and left subclavian artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm；
✓. Suitable arterial access for endovascular interventional treatment;

✕. Previously received open surgery or endovascular intervention for descending aorta or abdominal aorta;
✕. Infectious aortic disease, takayasu arteritis, Marfan syndrome (or other connective tissue diseases );
✕. Patients that have experienced systemic infection within past three months;
✕. Neck surgery was performed within past three months;
✕. Patients with severe stenosis, calcification, thrombosis or tortuosity in the brachiocephalic trunk, left common carotid artery or left subclavian artery;
✕. Patients with intestinal necrosis and lower limb ischemic necrosis;
✕. Paraplegic patients;
✕. Heart transplant patients;