Skip to content

A prospective, multi-center, single-arm study to evaluate the safety and efficacy of endovascular interventional sysetm in endovascular abdominal aortic aneurysm repair

A prospective, multi-center, single-arm study to evaluate the safety and efficacy of endovascular interventional sysetm in endovascular abdominal aortic aneurysm repair

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066212
Enrollment
Unknown
Registered
2022-11-28
Start date
2022-12-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Aortic disease

Interventions

Robot assisted surgery:Robot assisted surgery

Sponsors

Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Age above 18 (including 18), regardless of gender 2) Intraaortic interventional surgery is required (if any of the following criteria is met) (1) Thoracic aortic aneurysm: diameter>5.5 cm (2) Abdominal aortic aneurysm: male, tumor diameter>5.0 cm; Female, tumor diameter > 4.5cm (3) Eccentric saccular aneurysm, diameter>4cm (4) Aortic aneurysm diameter expansion, speed > 10mm/year (5) Those who have chest pain or abdominal pain and cannot rule out ruptured aneurysm 3) Volunteer to participate in the test, and can sign the informed consent form

Exclusion criteria

Exclusion criteria: 1) Pregnant or lactating women, or women of childbearing age with positive pregnancy test results. 2) Aortic aneurysm has been ruptured or has signs of rupture (including but not limited to: periaortic leakage, retroperitoneal hematoma, contrast medium overflow) 3) Infectious or hereditary diseases cause connective tissue lesions that cause aortic aneurysms. 4) There are contraindications to anticoagulation. 5) Contraindication of contrast medium. 6) Subjects participated in other clinical trials within 3 months before the screening period. 7) Infectious aortic aneurysm. 8) Vascular conditions are not suitable for endovascular repair. 9) The researcher thinks that it is not suitable for other situations.

Design outcomes

Primary

MeasureTime frame
Device technical success rate;Clinical success rate;Evaluation of device operation performance;

Secondary

MeasureTime frame
Single operation radiation exposure;

Countries

China

Contacts

Public ContactQingshenlu

Shanghai Changhai Hospital

luqs@newvascular.cn021-31166666

Outcome results

None listed

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