The Neuroprotective Effect of Remote Ischemic Conditioning in Ruptured Aneurysm Coiling Therapy (NEAT-2)

Capital Medical University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Coiling Therapy; Aneurysm, Ruptured

Treatments: Device: sham remote ischemic conditioning; Device: remote ischemic conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT03561311

2017-NEAT-2

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
• Ruptured 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
• Renal insufficiency with creatinine ≥ 265 umol/L
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 2 patient groups

Remote ischemic conditioning group

Experimental group

Treatment:

Device: remote ischemic conditioning

Sham remote ischemic conditioning group

Sham Comparator group

Treatment:

Device: sham remote ischemic conditioning