Outcome Study of the Pipeline Embolization Device With Vantage Technology in Unruptured Aneurysms
- Conditions
- Brain AneurysmStrokeIntracranial Hemorrhages
- Registration Number
- NCT05626504
- Lead Sponsor
- King's College Hospital NHS Trust
- Brief Summary
In this project the investigators study the safety and efficacy of the pipeline embolization device with vantage technology in treatment of unruptured brain aneurysms
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- All patients treated with Pipeline Embolization Device with Vantage Technology (PEDV)
- MRA and/or DSA (or tomographic angiography) available for follow up
- Insufficient background data available e.g., to determine size of aneurysm and pipeline device
- PEDV used for causes other than aneurysms, e.g., fistulas and dissection.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate 30-day morbidity rates Done at 30 days post procedural We will evaluate short term clinical outcome in the form of morbidity rates 30 days after the procedure
Evaluate 30-day mortality rates Done at 30 days post procedural We will evaluate short term clinical outcome in the form of mortality rates 30 days after the procedure
- Secondary Outcome Measures
Name Time Method Evaluate 1-year morbidity rates Done at >30days up to 1 year post procedural We will evaluate long term clinical outcome in the form of morbidity rates \>30days up to 1 year after the procedure
Evaluate 1-year mortality rates Done at >30days up to 1 year post procedural We will evaluate long term clinical outcome in the form of mortality rates \>30days up to 1 year after the procedure
Trial Locations
- Locations (1)
Kings College Hospital
🇬🇧London, United Kingdom