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Evaluation of the Safety and Efficacy of Customized Domestic Aortic Stent-Graft System

Evaluation of the Safety and Efficacy of Customized Domestic Aortic Stent-Graft System

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062377
Enrollment
Unknown
Registered
2022-08-03
Start date
2022-08-01
Completion date
Unknown
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic arch pathologies

Interventions

single arm:Aortic stent-graft implantation

Sponsors

Zhongshan Hospital Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Ageg >=18 years old; 2) Signed the informed consent by himself or the legal representative; 3) Patients diagnosed with thoracoabdominal aortic aneurysm; 4) Unobstructed iliac and femoral artery access; 5) The length of the proximal aneurysm neck of the aortic aneurysm is >= 15mm, and the distal landing zone of the aortic aneurysm is >= 15mm; 6) Morphologically suitable for endovascular repair; 7) The patient has at least a survival expectation of more than 1 year.

Exclusion criteria

Exclusion criteria: 1) The patient is a pregnant or breastfeeding woman; 2) The patient has a history of surgical repair or endovascular treatment of the aorta; 3) The patient had myocardial infarction or stroke within 3 months before enrollment; 4) The patient has connective tissue disease or active systemic infection; 5) The patient has severe coagulation disorder; 6) Not suitable for patients specified by the specifications of this device; 7) The length of the proximal anchoring zone of thoracoabdominal aortic aneurysm is less than 25mm; 8) Patients with contraindications to X-rays; 9) Those who are allergic to stent materials; 10) The patient has renal insufficiency and cannot tolerate contrast media; 11) Patients who are allergic to contrast agents; 12) The patient has mural thrombus near and distal to the aneurysm.

Design outcomes

Primary

MeasureTime frame
Postoperative disease progression and stent status;

Secondary

MeasureTime frame
Incidence of major adverse events related to surgery or device;Immediate technical success following surgery;

Countries

China

Contacts

Public ContactWeiguo Fu
fu.weiguo@zs-hospital.cn+86 13801760929

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026