Oriental Research AlliaNce of Acute Ischemic Stroke Given Endovascular Treatment

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-95
SponsorShanghai Jiao Tong University Affiliated Sixth People's Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,;

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;

Patients with a score of at least 6 on the Alberta Stroke Program Early CT score (ASPECTS) value;

Baseline multimodal-CT imaging, including NCCT, CTA and CTP, performed at the trial-site hospital

Disqualifiers

Stoke of large artery atherosclerotic origin or other determined factors (such as dissection) or tandem occlusion;

Patients underwent rescue angioplasty or stenting after thrombectomy

Trial population

Patients were treated according to national guidelines for treatment of AIS, including intravenous thrombolysis, if indicated. Thrombectomy were performed according to standard techniques. The method of endovascular therapy was selected at the discretion of treating physicians and could include stent retriever and/or catheter aspiration.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • rapid local ischemic postconditioning (RL-IPostC)

    Procedure/Surgery

    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 groups

160 Participants
are divided into 2 treatment groups
Group A: rapid local ischemic postconditioning (RL-IPostC) group1 intervention
Group B: control group0 interventions

Trial outcomes

Primary outcomes

1

functional independence

mRS 0-2

Time frame
3 month

Secondary outcomes

1

excellent functional independence

mRS 0-1

Time frame
3 month
2

early therapeutic response

defined as a decrease in the NIHSS score of ≥10 from baseline or an NIHSS score of 0 or 1

Time frame
on day 5, 6, or 7 of hospitalization or at discharge if it occurred before day 5
3

Mortality

Mortality of 3 month after stoke onset

Time frame
3 month
4

hemorrhagic transformation

according to European Cooperative Acute Stroke Study II criteria

Time frame
24 hours after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Lead sponsor

Zhangzhou Municipal Hospital of Fujian Province

Collaborator