Type II Endoleak after Endovascular Aortic Repair
Conditions
Interventions
Test group:Endovascular Aortic Repair (EVAR) Combined with Aortic Occlusion Device for Embolization
Control group:Endovascular abdominal aortic repair
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Age >=18 years, regardless of gender; (2) Abdominal aortic aneurysm (AAA) diameter >5.0 cm (male) or >4.5 cm (female); or rapid AAA growth (>10 mm/year); and scheduled for endovascular aortic repair (EVAR); (3) Preoperative CTA indicates high-risk Type II endoleak, meeting at least one of the following criteria: a. Patent inferior mesenteric artery (IMA) with diameter >=3 mm; b. Patent lumbar artery (LA) with diameter >=2 mm; c. Number of patent lumbar arteries (LA) >3; (4) The participant or their legal representative understands the study purpose, voluntarily participates, signs the informed consent form, and agrees to comply with clinical follow-up.
Exclusion criteria
Exclusion criteria: (1) Patients with ruptured, leaking, inflammatory, or infected (mycotic) aneurysms (2) Preoperative CTA showing unfavorable aneurysm anatomy:Neck length 15mm with ß-angle >75° or a-angle >60°, Neck length >10mm with ß-angle >60° or a-angle >45°); Neck diameter >30mm (3) Vascular disease or anatomical constraints preventing safe catheter access or device placement (4) Planned non-standard EVAR procedures (e.g., fenestrated or branched endograft repair) (5) History of stroke or transient ischemic attack (TIA) within 3 months prior to surgery (6) Myocardial infarction and/or major cardiac surgery within 3 months before procedure (7) Severe hepatic or renal dysfunction:Serum creatinine (Scr) >=3×ULN and/or end-stage renal disease requiring dialysis; ALT or AST >=5×ULN; Total bilirubin (T-Bil) >=3×ULN (8) Uncontrolled active infection or sepsis (9) Connective tissue disorders (e.g., Marfan syndrome) (10) Active bleeding (non-aneurysm related) or clinically significant coagulation abnormalities (investigator's discretion) (11) Known allergies to investigational devices (e.g., nitinol), contrast agents, or anticoagulants (12) Previous abdominal aortic aneurysm-related surgeries (13) Thrombus occupying >60% of aneurysm sac (14) Life expectancy <12 months (e.g., due to malignancy) (15) Pregnant or lactating women (16) Current participation in other drug or medical device clinical trials (17) Other conditions considered unsuitable for trial participation by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Type II Endoleak Incidence Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device Success Rate;Procedure Success Rate;Type II Endoleak Incidence Rate;Type I Endoleak Incidence Rate;Type III Endoleak Incidence Rate;Aneurysm Sac Thrombosis Status (No thrombosis / Partial thrombosis / Complete thrombosis) ;Maximum Aneurysm Sac Diameter Change;Aneurysm Sac Volume Change; | — |
Countries
China
Contacts
Public ContactXiangchen Dai
Tianjin Medical University General Hospital
Outcome results
None listed