RecruitingNot Applicable

Safety and Efficacy of a Multi-branched Thoracoabdominal Stent Graft System for Thoracoabdominal Aortic Aneurysm.

China73 participantsStarted 2021-11-12

Plain-language summary

Evaluation of the safety and efficacy of a multi-branched thoracoabdominal stent graft system for thoracoabdominal aortic 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.

✓. 18 years old ≤ age ≤ 80 years old;
✓. Diagnosed as thoracoabdominal aortic aneurysm (based on modified Crawford classification and 2019 European Guidelines for the Treatment of Aortic aneurysm) and should meet at least one of the following conditions;
✓. Maximum diameter of thoracoabdominal aortic aneurysm\>50mm;
✓. The diameter has increased by more than 5mm in recent 6 months or the by more than 10mm in recent 1 year;
✓. anatomical criteria
✓. The proximal anchoring region (aorta or implanted graft) was 17\~36 mm in diameter and ≥25 mm in length;
✓. Distal anchoring region (aorta or implanted graft): If the distal anchoring region is in the iliac artery, the anchoring region has a diameter range of 7\~25 mm and a length of ≥15 mm; If the distal anchoring area is in the abdominal aorta, the diameter of the anchoring area ranges from 12\~36mm and the length≥ 20mm;
✓. The diameter of the vessel anchoring area of the visceral branch ranges from 6\~13 mm and the length ≥15 mm;

✕. Hemodynamically unstable patients with ruptured thoracoabdominal aortic aneurysms;
✕. Thoracoabdominal aortic dissection;
✕. Mycotic or infectious thoracoabdominal aortic aneurysm;
✕. Patients whose systemic or local infection may increase the risk of intravascular graft infection;
✕. Superior mesenteric, celiac, or renal artery occlusion;
✕. Requiring simultaneous coverage and embolization of bilateral internal iliac arteries;
✕. Severe stenosis, calcification, or mural thrombus in the anchoring area of the stent tend to have difficulty in attachment of the stent-graft or affect the patency of the stent;
✕. A history of acute coronary syndrome within 6 months; Acute coronary syndrome is defined as an acute ischemic syndrome of the heart resulting from the rupture or erosion of unstable intracoronary atherosclerotic plaques followed by fresh thrombosis, including ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, and unstable angina pectoris.

Primary safety endpoint: The incidence of Major Adverse events (MAE) within 30 days after procedure.

Timeframe: Within 30 days after procedure

Primary efficacy endpoint: Success rate of thoracoabdominal aortic aneurysm treatment 12 months after procedure.

Timeframe: 12 months after procedure.

NCT IDNCT05054985

SponsorLifetech Scientific (Shenzhen) Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-31

Wei Guo, Professor

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.

✓. 18 years old ≤ age ≤ 80 years old;
✓. Diagnosed as thoracoabdominal aortic aneurysm (based on modified Crawford classification and 2019 European Guidelines for the Treatment of Aortic aneurysm) and should meet at least one of the following conditions;
✓. Maximum diameter of thoracoabdominal aortic aneurysm\>50mm;
✓. The diameter has increased by more than 5mm in recent 6 months or the by more than 10mm in recent 1 year;
✓. anatomical criteria
✓. The proximal anchoring region (aorta or implanted graft) was 17\~36 mm in diameter and ≥25 mm in length;
✓. Distal anchoring region (aorta or implanted graft): If the distal anchoring region is in the iliac artery, the anchoring region has a diameter range of 7\~25 mm and a length of ≥15 mm; If the distal anchoring area is in the abdominal aorta, the diameter of the anchoring area ranges from 12\~36mm and the length≥ 20mm;
✓. The diameter of the vessel anchoring area of the visceral branch ranges from 6\~13 mm and the length ≥15 mm;

✕. Hemodynamically unstable patients with ruptured thoracoabdominal aortic aneurysms;
✕. Thoracoabdominal aortic dissection;
✕. Mycotic or infectious thoracoabdominal aortic aneurysm;
✕. Patients whose systemic or local infection may increase the risk of intravascular graft infection;
✕. Superior mesenteric, celiac, or renal artery occlusion;
✕. Requiring simultaneous coverage and embolization of bilateral internal iliac arteries;
✕. Severe stenosis, calcification, or mural thrombus in the anchoring area of the stent tend to have difficulty in attachment of the stent-graft or affect the patency of the stent;
✕. A history of acute coronary syndrome within 6 months; Acute coronary syndrome is defined as an acute ischemic syndrome of the heart resulting from the rupture or erosion of unstable intracoronary atherosclerotic plaques followed by fresh thrombosis, including ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, and unstable angina pectoris.