peripheral arterial aneurysm
Conditions
Interventions
Test group:Treatment of arterial aneurysms using detachable peripheral embolization coils manufactured by Hunan Apt Medical Device Co., Ltd.
Control group:Treatment of arterial aneurysms using Boston detachable peripheral embolization coils produced by Boston Scientific International Medical Trading (Shanghai) Co., Ltd.
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18–80 years, any sex; 2. Aneurysms requiring transcatheter embolization confirmed by imaging (e.g., ultrasound, CTA, MRA); 3. Confirmed arterial aneurysms, including splenic artery aneurysms, abdominal aortic/iliac aneurysms requiring branch embolization; 4. Able to understand the study and sign informed consent (self or legal representative).
Exclusion criteria
Exclusion criteria: 1. Hemodynamically unstable patients. 2. High-flow arteriovenous fistulas or AVM malformations likely to cause embolic material migration, or lesions unsuitable for coil-only embolization. 3. Target vessels requiring staged/stepwise embolization procedures. 4. Known allergy or contraindication to contrast agents, or history of allergy to platinum–tungsten alloy or polyethylene terephthalate (PET). 5. Severe cardiac, hepatic, renal, respiratory diseases, or coagulation disorders making anesthesia or endovascular treatment unsuitable. 6. Life expectancy less than 1 year. 7. Pregnant or breastfeeding women, or those planning pregnancy within one year. 8. Participation in another drug or device clinical study, or expected to require participation in another such study after enrollment. 9. Any other condition deemed unsuitable for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Target vessel occlusion rate;Reintervention rate;Device success rate;Health economic evaluation;All-cause mortality rate;Device- or procedure-related adverse event rate;Incidence of adverse event;Incidence of serious adverse event;Incidence of Device Defects; | — |
Countries
China
Contacts
Public ContactDai Xiangchen
Tianjin Medical University General Hospital
Outcome results
None listed