A Prospective Multicenter, Single-Arm Clinical Trial to Evaluate the Efficacy of Stent Graft System to Treat Abdominal Aortic Aneurysm

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400083387

Enrollment

Unknown

Registered

2024-04-23

Start date

2024-04-25

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Abdominal Aortic Aneurysm

Interventions

Test group:The Stent Graft System will be used to treat Abdominal Aortic Aneurysm.

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Age 18 to 80 years old 2) Diagnosis as infrarenal abdominal aortic aneurysm with the following characteristics: Supra-renal and infra-renal angulations = 60°; Proximal aortic neck is 17-31 mm in diameter; Iliac fixation length = 15 mm; Abdominal aortic aneurysm diameters has at least one of the following: ? Male abdominal aortic aneurysm (AAA) size >50mm ? Female abdominal aortic aneurysm (AAA) size >45mm ? Increase of the AAA diameter of >10mm over the last year 3) Willing to sign the informed consent form

Exclusion criteria

Exclusion criteria: 1) Surgical procedure or EVAR prior to the index procedure 2) Have had a myocardial infarction (MI) or unstable angina pectoris (UAP) within 3 months prior to implantation 3) Have had a transient ischemic attack(TIA)or cerebral vascular accident (CVA) within 3 months 4) Severe stenosis and/or calcium formation and/or aortic mural thrombus at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface. 5) Unsuitable iliac-femoral artery approach 6) Known contraindication to anticoagulation or antiplatelet 7) ALT or AST > 2.5 times the upper limit of normal 8) Have a creatinine >2 times the upper limit of normal or on dialysis 9) Uncontrolled systemic infection (e.g. bacteraemia, pyotoxinemia,etc.) 10) Mental disorders/History of Mental disorders/Inability to cooperate autonomously 11) Lactating, pregnant or planning pregnant women 12) in other interventional clinical investigations 13) Not suitable for inclusion in the clinical investigation in the judgment of the investigator

Design outcomes

Primary

Measure	Time frame
Treatment success rate of abdominal aortic aneurysm at 12 Months;	—

Secondary

Measure	Time frame
Technical Success Rate;Incidence of MAE within 30d;Incidence of Secondary Intervention;Product Performance Evaluation;	—

Countries

China

Contacts

Public ContactChang Shu

Fuwai Hospital

changshu01@yahoo.com+86 731 8529 5832

Outcome results

None listed

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