UnknownNot Applicable

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

China20 participantsStarted 2022-11-10

Plain-language summary

To explore the effect and prognosis of endovascular interventional therapy in high-risk patients with aortic arch dissection and aneurysm

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.
✓. The patient was diagnosed with subacute or chronic aortic arch dissection, or Aortic arch aneurysms.
✓. Patients 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;
✓. Innominate artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm；
✓. Left common carotid artery or left subclavian artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm；

✕. Patients that have experienced systemic infection during past three months;
✕. Neck surgery was performed within three months;
✕. Infectious aortic disease、Takayasu arteritis，Marfan syndrome (or other connective tissue diseases );
✕. Patients with severe stenosis, calcification, thrombosis or tortuosity of the Brachiocephalic trunk, Left common carotid artery or left subclavian artery;
✕. Heart transplant patients;
✕. Patients that have suffered MI or stroke during past three months;
✕. Patients with Class IV heart function (NYHA classification) or LVEF\<30%
✕. Active peptic ulcers or upper gastrointestinal bleeding occurring within the previous three months;

All-cause mortality and major stroke within 12 months after surgery.

Timeframe: 12 months post-intervention

NCT IDNCT05754541

SponsorHangzhou Endonom Medtech Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-31

Wei Guo

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.
✓. The patient was diagnosed with subacute or chronic aortic arch dissection, or Aortic arch aneurysms.
✓. Patients 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;
✓. Innominate artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm；
✓. Left common carotid artery or left subclavian artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm；

✕. Patients that have experienced systemic infection during past three months;
✕. Neck surgery was performed within three months;
✕. Infectious aortic disease、Takayasu arteritis，Marfan syndrome (or other connective tissue diseases );
✕. Patients with severe stenosis, calcification, thrombosis or tortuosity of the Brachiocephalic trunk, Left common carotid artery or left subclavian artery;
✕. Heart transplant patients;
✕. Patients that have suffered MI or stroke during past three months;
✕. Patients with Class IV heart function (NYHA classification) or LVEF\<30%
✕. Active peptic ulcers or upper gastrointestinal bleeding occurring within the previous three months;