Oriental Research AlliaNce of Acute Ischemic Stroke Given Endovascular Treatment (ORANGE)

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Ischemic Stroke

Treatments: Procedure: rapid local ischemic postconditioning (RL-IPostC)

Study type: Observational

Funder types: Other

Identifiers

NCT05024292

2021MT

Details and patient eligibility

About

To determine the safety and efficacy of in situ ischemic postconditioning immediately after successful reperfusion in AIS patients underwnet EVT.

Full description

For acute ischemic stroke (AIS) patients with large vessel occlusion in the anterior circulation receieved successful reperfusion, in situ ischemic postconditioning (ISIPC) was performed immediately after successful reperfusion with 5 circules of balloon inflations in the ipsilateral internal carotid artery, each circulation includes inflation lasting 15 seconds followed by 15 seconds of deflation.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult (age ≥ 18 to 95 years) patients with an occlusion of the internal carotid artery or M1 or M2 segment of the middle cerebral artery,;
2. Patients with a score of at least 6 on the National Institutes of Health Stroke Scale (NIHSS) at admission and a score of 0 or 1 on the modified Rankin scale before the onset of stroke;
3. Patients with a score of at least 6 on the Alberta Stroke Program Early CT score (ASPECTS) value;
4. Baseline multimodal-CT imaging, including NCCT, CTA and CTP, performed at the trial-site hospital
5. The modified thrombolysis in cerebral infarction (mTICI) scale 2b to 3 achieved in the infarct-related artery after the last thrombectomy attempt

Exclusion criteria

1. Stoke of large artery atherosclerotic origin or other determined factors (such as dissection) or tandem occlusion;
2. Patients underwent rescue angioplasty or stenting after thrombectomy

Trial design

160 participants in 2 patient groups

rapid local ischemic postconditioning (RL-IPostC) group

Description:

RL-IPostC is performed immediately after successful reperfusion with 5 circules of balloon inflations in the ipsilateral internal carotid artery, each circulation includes inflation lasting 15 seconds followed by 15 seconds of deflation.

Treatment:

Procedure: rapid local ischemic postconditioning (RL-IPostC)

control group

Description:

no intervention was provided after successful reperfusion