Rapid Local Ischemic Postconditioning in Acute Ischemic Stroke (RAPID-SAVE)

March 9, 2024 updated by: Yueqi Zhu, Shanghai Jiao Tong University Affiliated Sixth People's Hospital

A Multicenter, Open Label, Blind Endpoint, Clinical Trial to Evaluate the Efficacy and Safety of Rapid Local Ischemic Postconditioning in Acute Ischemic Stroke Patients Received Successful Thrombectomy Reperfusion

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This will be an umbrella trial of testing the efficacy and safety of three postconditioning intervention doses. It will be a prospective, open-label, blinded endpoint, three-dose Bayesian Optimal Phase 2(BOP2) design trial with interim efficacy and safety monitoring. The maximum number of subjects for this trial is estimated as 135 patients. Eligible patients are 18 years or older with symptomatic large vessel occluded (LVO) AIS treated with mechanical thrombectomy (MT) achieving successful reperfusion defined as mTICI score 2b or 3. Patients will receive 5 cycles of balloon inflation/deflation at ipsilateral C1 segment of internal carotid artery (ICA) for the temporary occlusion of the restoration of antegrade blood flow. Three postconditioning intervention doses of 30s/30s, 60s/60s and 180s/180s were adopted for block and restore of blood blow. The primary outcome is a favorable binary outcome defined as no clinically meaningful brain swelling from baseline to 24 hours and no clinically meaningful infarction growth from baseline to 24 hours and no causally attributable serious adverse events (SAEs). It's a composite outcome of efficacy and safety outcome. Key secondary outcomes include efficacy outcome indicating no clinically meaningful brain swelling defined by cerebral spinal fluid (CSF) volume reduction≤5 mL from baseline to 24 hours and safety outcome indicating infarct volume growth>10 mL from baseline to 24 hours or causally attributable SAEs. Other secondary outcomes include change of brain net water uptake, midline shift and functional outcome. For each intervention dose, we will perform the interim analyses following pre-defined optimized Bayesian rule for early stopping to make a go/no-go decision when the number of enrolled patients reaches 10, 20, 30. The optimal intervention dose will be determined according to the number of patients reach the primary endpoints in different groups.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
135

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years old
  2. Presenting with symptoms consistent with acute ischemic stroke
  3. Pre-stroke mRS score 0-1
  4. Baseline NIHSS score≥6
  5. Endovascular treatment can be initiated (femoral puncture) within 24 hours from stroke onset (stroke onset time is defined as last known well time)
  6. 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
  7. 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.
  8. Embolism verified as the etiology of occluded artery and mTICI 2b or 3 regained after mechanical thrombectomy
  9. Informed consent signed

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: RL-IPostC 30
The RL-IPostC 30 protocol involved 5 cycles of blow block and restoration, each for 30 seconds.
Procedure: rapid local ischemic postconditioning
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.
Other: RL-IPostC 60
The RL-IPostC 60 protocol involved 5 cycles of blow block and restoration, each for 60 seconds.
Procedure: rapid local ischemic postconditioning
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.
Other: RL-IPostC 180
The RL-IPostC 180 protocol involved 5 cycles of blow block and restoration, each for 180 seconds.
Procedure: rapid local ischemic postconditioning
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants without clinically meaningful cerebral swelling, significant increase in infarct volume from baseline and intervention-related serious adverse events.
Time Frame: 24 hours after procedure
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of participants without clinically meaningful cerebral swelling
Time Frame: 24 hours after procedure
No clinically meaningful brain swelling defined by CSF volume reduction≤5 mL from baseline to 24 hours.
24 hours after procedure
Rate of participants with significant increase in infarct volume from baseline or intervention-related serious adverse events.
Time Frame: 24 hours after procedure
Significant increase in infarct volume from baseline defined as an increase in infarct volume of more than 10 mL. Intervention-related serious adverse events defined as SAEs specifically related to RL-IPostC other than mechanical thrombectomy.
24 hours after procedure
Change in volume of cerebrospinal fluid (∆CSF72) at 72 hours
Time Frame: 72 hours after procedure
Change in volume of cerebrospinal fluid (∆CSF72) at 72 hours from baseline
72 hours after procedure
Change of net water uptake (∆NWU24) at 24 hours
Time Frame: 24 hours after procedure
Change of net water uptake (∆NWU24) at 24 hours from baseline
24 hours after procedure
Change of net water uptake (∆NWU72) at 72 hours
Time Frame: 72 hours after procedure
Change of net water uptake (∆NWU72) at 72 hours from baseline
72 hours after procedure
Midline shift at 24 hours
Time Frame: 24 hours after procedure
Distance of midline shift at 24 hours (in millimeters at the level of the septum pellucidum)
24 hours after procedure
Midline shift at 72 hours
Time Frame: 72 hours after procedure
Distance of midline shift at 72 hours (in millimeters at the level of the septum pellucidum)
72 hours after procedure
Change of NIHSS at 24 hours
Time Frame: 24 hours after procedure
Change of NIHSS at 24 hours from baseline
24 hours after procedure
Early therapeutic response to treatment
Time Frame: 24 hours after procedure
Decrease in the NIHSS score of ≥8 from baseline or an NIHSS score of 0 to 2 at 24 hours)
24 hours after procedure
Good outcome at 90 days
Time Frame: 90 days after procedure
Proportion of mRS score of 0 to 2 at 90 days
90 days after procedure
Excellent outcome at 90 days
Time Frame: 90 days after procedure
Proportion of mRS score of 0 to 1 at 90 days
90 days after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
First People's Hospital of Hangzhou
RenJi Hospital
Shanghai East Hospital
Zhangzhou Municipal Hospital of Fujian Province

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yueqi Zhu, MD, Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RAPID-SAVE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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