Rapid Local Ischemic Postconditioning in Acute Ischemic Stroke

NCT06307743 | Not Yet Recruiting DMC

• 1 other identifier: RAPID-SAVE
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this clinical trial is to determine whether rapid local ischemic postconditioning (RL-IPostC) is effective in preventing brain edema and safe in acute ischemic stroke (AIS) patients treated with mechanical thrombectomy. In this trial, researchers will block antegrade cerebral blood flow temporarily by the way of balloon inflation/deflation in AIS patients immediately after revascularization. It makes the ischemic reperfusion brain tissue have a capacity of adaptation through intermittent blood flow restoration. Researchers will evaluate the protective role and safety of different duration of balloon inflation/deflation. The optimal postconditioning intervention dose will be determined for further confirmative investigation.

Conditions

Acute Ischemic Stroke; Mechanical Thrombectomy; Ischemic Postconditioning; Brain Edema

Outcome Measures

Primary Outcomes (1)

• Number of Participants without clinically meaningful cerebral swelling, significant increase in infarct volume from baseline and intervention-related serious adverse events.

  No clinically meaningful cerebral swelling defined as volume reduction of cerebrospinal fluid ≤ 5 mL from baseline. No significant increase in infarct volume from baseline defined as an increase in infarct volume of ≤ 10 mL. Intervention-related serious adverse events defined as SAEs specifically related to RL-IPostC other than mechanical thrombectomy.

  24 hours after procedure

Secondary Outcomes (11)

• Rate of participants without clinically meaningful cerebral swelling

  24 hours after procedure

• Rate of participants with significant increase in infarct volume from baseline or intervention-related serious adverse events.

  24 hours after procedure

• Change in volume of cerebrospinal fluid (∆CSF72) at 72 hours

  72 hours after procedure

• Change of net water uptake (∆NWU24) at 24 hours

  24 hours after procedure

• Change of net water uptake (∆NWU72) at 72 hours

  72 hours after procedure

Study Arms (3)

RL-IPostC 30

OTHER

The RL-IPostC 30 protocol involved 5 cycles of blow block and restoration, each for 30 seconds.

Procedure: rapid local ischemic postconditioning

RL-IPostC 60

OTHER

The RL-IPostC 60 protocol involved 5 cycles of blow block and restoration, each for 60 seconds.

Procedure: rapid local ischemic postconditioning

RL-IPostC 180

OTHER

The RL-IPostC 180 protocol involved 5 cycles of blow block and restoration, each for 180 seconds.

Procedure: rapid local ischemic postconditioning

Interventions

rapid local ischemic postconditioning PROCEDURE

Rapid local ischemic postconditioning (RL-IPostC) is performed immediately (within 5 minutes) after revascularization. A balloon guiding catheter (BGC) positioned on ipsilateral C1 segment of internal carotid artery is inflated and deflated for the temporary occlusion of the antegrade flow.

RL-IPostC 180; RL-IPostC 30; RL-IPostC 60

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Presenting with symptoms consistent with acute ischemic stroke
• Pre-stroke mRS score 0-1
• Baseline NIHSS score≥6
• Endovascular treatment can be initiated (femoral puncture) within 24 hours from stroke onset (stroke onset time is defined as last known well time)
• Occlusion of the intracranial internal carotid artery, or the middle cerebral artery(M1 or M2) confirmed by CTA or MRA, and is the culprit artery
• Alberta Stroke Program Early CT Score (ASPECTS) (based on non-contrast CT) \>5 on noncontrast computed tomography (NCCT) for stroke onset time less than 6 hours, infarct Core \< 70 ml (defined as rCBF \<30% on CT perfusion) and mismatch ratio \> 1.2 (penumbra defined as Tmax \>6 seconds volume) for stroke onset time between 6 and 24 hours.
• Embolism verified as the etiology of occluded artery and mTICI 2b or 3 regained after mechanical thrombectomy
• Informed consent signed

You may not qualify if:

• Stenosis of the proximal middle cerebral artery, internal carotid artery, or common carotid artery (≥50%) of the culprit artery
• Multiple vascular embolism on different pathways (not refers to the ipsilateral middle artery and anterior artery)
• Pre ischemic stroke or transient ischemic attack within past 3 months
• The expected survival time is less than 6 months, could not be followed at 90 days (such as patient with malignant tumor)
• Currently pregnant, mental disease, advanced hepatic and renal insufficiency, severe heart failure
• Participation in other interventional randomized clinical trials that may confound the outcome assessment of the trial
• Other circumstances that the investigator considers inappropriate for this trial

Sponsors & Collaborators

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: lead
• Zhangzhou Municipal Hospital of Fujian Province: collaborator
• Shanghai East Hospital: collaborator
• First People's Hospital of Hangzhou: collaborator
• RenJi Hospital: collaborator

MeSH Terms

Conditions

Ischemic Stroke; Brain Edema

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yueqi Zhu, MD

  Shanghai Jiao Tong University Affiliated Sixth People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yueqi Zhu, MD

CONTACT

0086-21-64844183; zhuyueqi@hotmail.com

Jiangshan Deng, MD

CONTACT

0086-21-24058404; johnson120@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 13, 2024
• Study Start: March 15, 2024
• Primary Completion: June 15, 2025
• Study Completion: September 15, 2025
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share