Arteriovenous malformations
Conditions
Interventions
1:Application of Shenqi Medical's Qiyi peripherally detachable fiber-hair coil
Sponsors
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age =18 years old, =65 years old, gender is not limited; (2) Preoperative imaging (including but not limited to vascular ultrasound, CTA, MRA, etc.) diagnosis requires transcatheter embolization; (3) Imaging measurements of target blood vessels showed diameters ranging from 3mm to 30mm; (4) The subject or his legal guardian can understand the purpose of the study, demonstrate sufficient adherence to the study protocol, and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Subjects with unstable hemodynamics; (2) High-flow arteriovenous fistulas that may lead to embolic drift or arteriovenous malformations that cannot be treated by springs alone; (3) Embolization of target vessels should be completed in stages; (4) Major surgery such as femoral artery, aorta, or carotid artery surgery is performed within 30 days before screening or within the next 90 days; (5) Known to have a clear allergy or contraindication to contrast agents; (6) Subjects with severe heart, liver, kidney, respiratory system diseases and coagulopathy before surgery, which are not suitable for anesthesia or intravascular surgery; (7) Life expectancy is less than one year; (8) Pregnant or lactating women or those who plan to give birth within the next year; (9) Is participating in any other drug or medical device clinical trial or may participate after enrollment in this clinical trial Clinical trials with any other drug or medical device; (10) Other conditions deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occlusion of target vessel;Target vessel re intervention rate;Incidence of complications;Adverse event rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Target vessel subtotal occlusion rate;Instrument success rate; Excellent rate of instrument operation; | — |
Countries
China
Contacts
Public ContactLixin Su
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed