The Neuroprotective Effect of Remote Ischemic Conditioning in Aneurysm Coiling Therapy (NEAT)

Capital Medical University

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Aneurysm

Treatments

Device: sham remote ischemic conditioning

Device: remote ischemic conditioning

Study type

Interventional

Funder types

Other

Identifiers

NCT03496415

2017-NEAT

Details and patient eligibility

About

The overall incidence of DWI positive for thromboembolic events following endovascular treatment of intracranial aneurysms is proximately 50%. Whether remote ischemic conditioning was safe and effective to reduce ischemic brain lesions on DWI after endovascular treatment of intracranial aneurysms is still unclear. The investigators' hypothesis is that remote ischemic conditioning is a safe and effective strategy to reduce new ischemic lesions in intracranial aneurysms patients undergoing endovascular treatment.

Enrollment

210 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18 years or older
Unruptured brain aneurysm deemed suitable for neuroendovascular repair
Normal baseline brain MRI
Female subjects of childbearing potential have a negative pregnancy test.
Signed informed consent prior to entering study

Exclusion criteria

Dissecting or mycotic brain aneurysm.
Planned endovascular vessel sacrifice as the primary modality for aneurysm treatment
Severe, sustained hypertension (SBP > 185 mmHg or DBP > 110 mmHg)
Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs
Pre-morbid modified Rankin scale score of greater than 1
Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations
Patients who are unable to have an MRI scan for any reason.
Currently participating or previously participated in any investigational drug or device study within 6 months