Trials / Suspended
SuspendedNCT04062539
Total Cerebral Protection With Embolic Protection Devices Thoracic Aortic Stenting
Total Cerebral Protection With Embolic Protection Devices in Thoracic Aortic Stenting
- Status
- Suspended
- Phase
- —
- Study type
- Observational
- Enrollment
- 30 (estimated)
- Sponsor
- Imperial College London · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Stroke and silent cerebral infarction are a real risk with thoracic enodvascular aortic repair (TEVAR). The investigator propose to prospectively observational study with enrolment of all patients undergoing TEVAR for thoracic and thoracoabdominal conditions including aneurysmal degeneration, Type B dissection and acute aortic syndromes over a 24 month period, equating to a minimum of 20-30 patients per year. Patients undergoing juxtra-renal and infra-renal aortic stenting will form a control group.
Detailed description
TEVAR involves the insertion of a stent into the thoracic aorta to re-line it and prevent life-threatening haemorrhage from rupture, and ultimately death. The stent is inserted through a small cut in the femoral artery in the groin that is able to track to the desired location in the thoracic aorta over wires. The thoracic aorta and the branches it provides to supply the brain are diseased with atherosclerotic plaques and thrombus. The manipulation of wires and stents over these diseased locations can lead to small fragments breaking off and travelling to the brain to block the blood supply to areas of the brain (cerebral embolisation). Cerebral embolic protection devices (CEPDs) consist of filters that can be placed into the branches of the thoracic aorta that supply the brain(supra-aortic branches) before TEVAR and can capture and remove solid debris, preventing it from reaching the brain.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Sentinel and Spider | Dual filter and single filter |
Timeline
- Start date
- 2018-10-04
- Primary completion
- 2021-06-01
- Completion
- 2021-11-01
- First posted
- 2019-08-20
- Last updated
- 2019-08-22
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT04062539. Inclusion in this directory is not an endorsement.