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First-in-man safety and feasibility evaluation of endovascular surgical robotic system for thoracic/abdominal endovascular aortic repair in long-range delivery and operation of guidewire, catheter, and stentgraft/balloon catheter

First-in-man safety and feasibility evaluation of endovascular surgical robotic system for thoracic/abdominal endovascular aortic repair in long-range delivery and operation of guidewire, catheter, and stentgraft/balloon catheter

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082087
Enrollment
Unknown
Registered
2024-03-20
Start date
2021-07-31
Completion date
Unknown
Last updated
2024-03-25

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

Conditions

aortic aneurysm

Interventions

Interventional group:Robotic-assisted endovascular aortic repair

Sponsors

Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Age = 18 years old, no gender limit; 2) Patients who need endovascular repair of thoracic/abdominal aortic disease; 3) Patients who can understand the purpose of the trial, are willing to participate, and sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1) Patients with aortic aneurysm rupture or impending rupture; 2) Patients with mycotic or infectious aortic aneurysm; 3) Patients with connective tissue diseases, such as Marfan syndrome, Ehlers-Danlos syndrome, or Behcet's disease; 4) Patients with a history of unstable angina pectoris within the past 6 months (gradually worsening angina symptoms, newly developed angina at rest or during sleep, or prolonged duration of angina); 5) Patients with transient ischemic attack (TIA) or ischemic stroke within the past 3 months; 6) Patients who have undergone aortic surgery or endovascular surgery; 7) Patients with contraindications to anticoagulation; 8) Active infection; 9) Patients with contraindications to contrast agents; 10) Patients with impaired liver and kidney function; 11) Patients who have participated in other pre-market studies or received experimental drugs or devices and have not reached the primary endpoint; 12) Female patients who are pregnant or lactating, or female patients of fertile age with positive pregnancy test results; 13) Other situations deemed unsuitable for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
technical success;device-related major adverse events;

Secondary

MeasureTime frame
clinical success;fluoroscopy time;radiation exposure of doctors;contrast medium volume;operation time;

Countries

China

Contacts

Public ContactLu Qingsheng

Department of Vascular Surgery, Shanghai Changhai Hospital

luqs@newvascular.cn+86 139 1729 2504

Outcome results

None listed

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