CompletedNot Applicable

Guo's Visceral Arteries Reconstruction: First in Man Study

China15 participantsStarted 2019-10-17

Plain-language summary

A First in man study to evaluate the safety and efficacy of thoracoabdominal aortic stent system for thoracoabdominal aortic aneurysms and pararenal abdominal aortic aneurysm.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Age ≥18 and ≤80 years;
✓. Patients diagnosed with type Crawford I-V thoracoabdominal aortic aneurysmsa and pararenal abdominal aortic aneurysm, and should meet at least one of the following conditions:
✓. The maximum diameter of thoracoabdominal aortic aneurysms and pararenal abdorminal aortic aneurysm \> 50 mm;
✓. Rapid growth of sac \>5 mm in diameter in the most recent 6 months;
✓. Definite symptoms of abdominal pain and low back pain associated with thoracicabdominal aortic aneurysms.
✓. Patients with four indispensable reno-visceral arteries including superior mesenteric artery, celiac trunk and bilaterial renal arteries.
✓. Proximal landing zone 20-36 mm in diameter;
✓. Proximal landing zone ≥25 mm in length;

Exclusion criteria

✕. Ruptured aortic aneurysm in unstable haemodynamic condition;
✕. Aneurysmal aortic dissection;
✕. Infected or mycotic aortic aneurysm;
✕. Requiring simultaneous coverage or embolisation for bilateral internal iliac arteries;
✕. Severe stenosis, calcification, or mural thrombus at stent-graft landing zone;
✕. Diagnosis of acute coronary syndrome within 6 months;
✕. Patients with any transient ischemic attack (TIA) or ischemic stroke within 3 months;
✕. An allergic history for contrast agents, anticoagulants, antiplatelet drugs, stent graft or materials of delivery system；

What they're measuring

Number of Participants With Major Adverse Events (MAE) Within 30 Days Postoperative

Timeframe: within 30-days postoperative

Trial details

NCT IDNCT04731636

SponsorLifetech Scientific (Shenzhen) Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-03-10

Results submitted2022-12-07

View on ClinicalTrials.gov More Thoracoabdominal Aortic Aneurysm trials