Acute Ischemic StrokePhase 1/2PROTECTNCT05909982
Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy (PROTECT-1b)
A Phase 1/2 study testing Mechanical thrombectomy combined with ischemic post-conditioning in people with Acute Ischemic Stroke and Reperfusion Injury, run by Capital Medical University at 1 site in China.
Trial summary
Ischemic post-conditioning is a neuroprotective strategy attenuating reperfusion injury in animal stroke models. The investigators have conducted a 3 + 3 dose-escalation trial to demonstrate the safety and tolerability of ischemic post-conditioning incrementally for a longer duration of up to 5 min × 4 cycles in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Reperfusion Injury
- What is being tested?
- Mechanical thrombectomy combined with ischemic post-conditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 28 Jan 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- Acute ischemic stroke within 24 hours from stroke onset (or from time last known well) to groin puncture;
- Previous mRS ≤ 2;
- Baseline NIHSS ≥ 6;
- Baseline ASPECTS ≥ 6;
- With an occlusion of unilateral middle cerebral artery M1 segment/distal intracranial carotid artery;
- Successful recanalization (mTICI ≥ 2b) after thrombectomy confirmed by DSA;
- Written informed consent provided by the patients or their legal relatives.
Who cannot join
- Confirmed or clinically suspected cerebral vasculitis/fibromuscular dysplasia;
- Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning;
- Stenting in the middle cerebral artery M1 segment/distal intracranial carotid artery during thrombectomy;
- > 2 times balloon dilations as rescue therapy due to angioplasty during thrombectomy;
- Moderate/severe residual stenosis (≥ 50%) in the offending artery after thrombectomy;
- Patients with contraindications to MRI;
- Other conditions that the investigator considered inappropriate for inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ischemic Post-conditioning on Infarct Volume in Patients With Acute Ischemic Stroke After Mechanical Thrombectomy
Ischemic post-conditioning is a neuroprotective strategy attenuating reperfusion injury in animal stroke models. The investigators have conducted a 3 + 3 dose-escalation trial to demonstrate the safety and tolerability of ischemic post-conditioning incrementally for a longer duration of up to 5 min × 4 cycles in stroke patients undergoing mechanical thrombectomy. This study aims to assess the infarct volume after ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.
- Conditions
- Acute Ischemic Stroke, Reperfusion Injury
- Being tested
- Mechanical thrombectomy combined with ischemic post-conditioning
- Medical subject headings
- Ischemic Stroke, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical thrombectomy combined with ischemic post-conditioningProcedure or surgery
Ischemic post-conditioning will be applied after successful recanalization of the culprit artery by thrombectomy. Ischemic post-conditioning consists of briefly repeated four cycles × 2 minutes of occlusion and reperfusion (equal duration) of the initially occluded artery using a balloon.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic post-conditioning group | Experimental | Mechanical thrombectomy combined with ischemic post-conditioning Receives: Procedure: Mechanical thrombectomy combined with ischemic post-conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct volume
Infarct volume at 72 hours after procedure
Measured: 72 hours after procedure
Secondary outcomes (9)
The progression of infarct volume
Difference of infarct volume between baseline and 72 hours after procedure
Measured: Baseline and 72 hours after procedure
The proportion of functional independence at 90 days
The modified Rankin Scale (mRS) score of 0-2 at 90 days after procedure; the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)
Measured: 90 days after procedure
The proportion of favorable outcome at 90 days
The mRS score of 0-3 at 90 days after procedure; the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)
Measured: 90 days after procedure
The distribution of the mRS score at 90 days
The distribution of the mRS score at 90 days after procedure; the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)
Measured: 90 days after procedure
National Institute of Health Stroke Scale (NIHSS) score
NIHSS score at 24 hours after procedure; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits
Measured: 24 hours after procedure
The proportion of early neurological improvement
NIHSS 0-2 or ≥8 lower than baseline NIHSS score at 24 hours after procedure; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits
Measured: 24 hours after procedure
NIHSS score at 7 days after procedure/discharge
NIHSS score at 7 days after procedure/discharge; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits
Measured: 7 days after procedure/discharge
Recanalization rate
Recanalization rate at 24 hours after procedure (mTICI ≥2b)
Measured: 24 hours after procedure
Hemodynamic assessment
Hemodynamic assessment within 24 hours after procedure
Measured: Within 24 hours after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Apr 2023
- Primary completion15 Oct 2023
- Study completion28 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909982
- Sponsor's protocol ID
- PROTECT-1b
- Acronym
- PROTECT
- Status last verified
- Mar 2025
- First submitted
- 9 Jun 2023
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Wu L, Zhang B, Zhao W, Ji X, Wei M. Ischemic post-conditioning in acute ischemic stroke thrombectomy: A phase-I duration escalation study. Front Neurosci. 2022 Dec 8;16:1054823. doi: 10.3389/fnins.2022.1054823. eCollection 2022.
PubMed 36523440Jiang X, Wu L, Liu S, Xu Y, Zhang B, Wang S, Luo L, Zhao W, Yao Y, Cao C, Zhao H, Ji X, Wei M. In situ ischemic postconditioning for acute ischemic stroke: preliminary exploratory study. J Neurointerv Surg. 2026 Jul 16;18(8):1757-1764. doi: 10.1136/jnis-2025-024031.
PubMed 40889891
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ischemic Post-conditioning on Infarct Volume in Patients With Acute Ischemic Stroke After Mechanical Thrombectomy
- ClinicalTrials.gov ID
- NCT05909982
- Acronym / sponsor ID
- PROTECT / PROTECT-1b
- Conditions
- Acute Ischemic Stroke, Reperfusion Injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 28 Jan 2024 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ischemic post-conditioning is a neuroprotective strategy attenuating reperfusion injury in animal stroke models. The investigators have conducted a 3 + 3 dose-escalation trial to demonstrate the safety and tolerability of ischemic post-conditioning incrementally for a longer duration of up to 5 min × 4 cycles in stroke patients undergoing mechanical thrombectomy. This study aims to assess the infarct volume after ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ischemic post-conditioning group | Experimental | Procedure: Mechanical thrombectomy combined with ischemic post-conditioningMechanical thrombectomy combined with ischemic post-conditioning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years;
- Acute ischemic stroke within 24 hours from stroke onset (or from time last known well) to groin puncture;
- Previous mRS ≤ 2;
- Baseline NIHSS ≥ 6;
- Baseline ASPECTS ≥ 6;
Key exclusion criteria (7 listed)
- Confirmed or clinically suspected cerebral vasculitis/fibromuscular dysplasia;
- Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning;
- Stenting in the middle cerebral artery M1 segment/distal intracranial carotid artery during thrombectomy;
- > 2 times balloon dilations as rescue therapy due to angioplasty during thrombectomy;
- Moderate/severe residual stenosis (≥ 50%) in the offending artery after thrombectomy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical thrombectomy combined with ischemic post-conditioningIschemic post-conditioning will be applied after successful recanalization of the culprit artery by thrombectomy. Ischemic post-conditioning consists of briefly repeated four cycles × 2 minutes of occlusion and reperfusion (equal duration) of the initially occluded artery using a balloon. | Procedure or surgery | Ischemic post-conditioning group |
Primary outcome
Infarct volume
Time frame: 72 hours after procedure
Infarct volume at 72 hours after procedure
9 secondary outcomes
The progression of infarct volume
Time frame: Baseline and 72 hours after procedure
The proportion of functional independence at 90 days
Time frame: 90 days after procedure
The proportion of favorable outcome at 90 days
Time frame: 90 days after procedure
The distribution of the mRS score at 90 days
Time frame: 90 days after procedure
National Institute of Health Stroke Scale (NIHSS) score
Time frame: 24 hours after procedure
The proportion of early neurological improvement
Time frame: 24 hours after procedure
NIHSS score at 7 days after procedure/discharge
Time frame: 7 days after procedure/discharge
Recanalization rate
Time frame: 24 hours after procedure
Hemodynamic assessment
Time frame: Within 24 hours after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Background: PubMed 36523440Wu L, Zhang B, Zhao W, Ji X, Wei M. Ischemic post-conditioning in acute ischemic stroke thrombectomy: A phase-I duration escalation study. Front Neurosci. 2022 Dec 8;16:1054823. doi: 10.3389/fnins.2022.1054823. eCollection 2022.
- Derived from this study: PubMed 40889891Jiang X, Wu L, Liu S, Xu Y, Zhang B, Wang S, Luo L, Zhao W, Yao Y, Cao C, Zhao H, Ji X, Wei M. In situ ischemic postconditioning for acute ischemic stroke: preliminary exploratory study. J Neurointerv Surg. 2026 Jul 16;18(8):1757-1764. doi: 10.1136/jnis-2025-024031.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mechanical thrombectomy combined with ischemic post-conditioning in people with Acute Ischemic Stroke and Reperfusion Injury, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct volume (time frame: 72 hours after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05909982, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.