Ischemic StrokeDICER-aLVONCT06940128
Direct Ischemic Conditioning for Endovascular Recanalization for Anterior Large Vessel Occlusion (DICER-aLVO)
A study testing Direct Ischemic Conditioning A, Direct Ischemic Conditioning B and Direct Ischemic Conditioning C in people with Ischemic Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
Acute ischemic stroke (AIS) is the most common type of stroke, with high incidence rate and mortality. Endovascular therapy is currently the most effective treatment for AIS with large vessel occlusion, but only about 50% of patients achieve good outcome after endovascular therapy, while 50% of patients have poor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Direct Ischemic Conditioning A, Direct Ischemic Conditioning B and Direct Ischemic Conditioning C
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- -1. Over 18 years old; 2. The time from onset to randomization is less than 24 hours; 3. Patients with acute anterior artery occlusion and receiving successful recanalization (mTICI 2b-3) after endovascular treatment and with residual stenosis ≤ 50%; 4. Cerebral circulation time after successful recanalization: affected side ≤ healthy side; 5. PH2 hemorrhage was excluded by immediate postoperative CT examination; 6. Re-onset patients with first onset or past onset without sequelae such as limb paralysis should not affect the score of this NIHSS, and mRS Score of patients with past onset should be less than 2 points; 7. Signed informed consent by patient or their legally authorized representative.
Who cannot join
- 1. Spherical enlargement of the lesion site twice or more; 2. Proximal residual stenosis >50% for patients with tandem lesions; 3. Intracranial hemorrhagic diseases: cerebral hemorrhage, subarachnoid hemorrhage, etc.
- 4. Chronic liver disease, liver and kidney insufficiency, elevated ALT or AST (greater than 2 times the upper limit of normal), elevated serum creatinine (greater than 1.5 times the upper limit of normal) or dependent on kidney dialysis; 5. Women who are pregnant, have a pregnancy plan or are breastfeeding; 6. Combined with serious other diseases, life expectancy < 6 months; 7. Other conditions deemed inappropriate for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
General Hospital of Northern Theater Command
Shengyang, Liaoning, 110016
Liang Liu, +86-024-28897499, 18580763671@163.com
About this study
Official title: Direct Ischemic Conditioning for Endovascular Recanalization for Anterior Large Vessel Occlusion (DICER-aLVO): a Prospective, Randomized, Open Label, Blinded-end Point, Phase 2, Multi-centre Study
Acute ischemic stroke (AIS) is the most common type of stroke, with high incidence rate and mortality. Endovascular therapy is currently the most effective treatment for AIS with large vessel occlusion, but only about 50% of patients achieve good outcome after endovascular therapy, while 50% of patients have poor prognosis, commonly referred to as ineffective perfusion. Therefore, how to improve ineffective perfusion is currently a hot topic.
Numerous studies have shown that Remote Ischemic Therapy (RIC) has a protective effect on ischemic stroke. Our recent RICAMIS study has demonstrated that RIC can significantly improve the functional prognosis of moderate acute ischemic stroke. Furthermore, direct ischemic conditioning has also showed neuroprotective effect. For example, in a rat model, within 2 minutes after reperfusion, using three cycles of 30 s reperfusion and 10 s occlusion for direct ischemic conditioning can effectively alleviate hyperperfusion and reduce cerebral infarction volume. Meanwhile, in previous clinical exploration studies, it was found that even induction by 5-minute ischemia and 5-minute reperfusion for up to 4 cycles is safe, feasible, and well tolerated for AIS patients receiving endovascular treatment. Immediate control of bilateral carotid artery blood flow after ischemia-reperfusion can significantly reduce cerebral infarction area and brain edema, and improve neurological function recovery in rats. Subsequent molecular mechanism studies have shown that direct ischemic conditioning can reduce the production of free radicals after cerebral ischemia-reperfusion, inhibit inflammatory reactions and cell apoptosis, downregulate the expression of signaling molecules mediating brain edema, promote Akt survival pathway, and improve the integrity of the blood-brain barrier, thereby exerting neuroprotective effects. Recent studies have also confirmed the safety and feasibility of direct ischemic conditioning for stroke patients achieving successful recanalization. More importantly, a recent cohort study has shown that direct ischemic conditioning can reduce infarct growth and brain edema after reperfusion in patients with AIS who have undergone thrombectomy for occlusion of large blood vessels in the anterior circulation, and improve prognosis after 90 days.
Based on the above discussion, this trial aims to evaluate the effectiveness and safety of direct ischemic conditioning for patients with AIS who have undergone thrombectomy for occlusion of large blood vessels in the anterior circulation.
- Conditions
- Ischemic Stroke
- Being tested
- Direct Ischemic Conditioning A, Direct Ischemic Conditioning B, Direct Ischemic Conditioning C
- Keywords
- Direct Ischemic Conditioning, stroke, Endovascular Recanalization
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Ischemic Conditioning AProcedure or surgery
Direct Ischemic Conditioning initiated within 5 minutes post-revascularization using either a balloon guiding catheter or a balloon catheter, positioned at the C1 segment of the ipsilateral internal carotid artery (ICA) to temporarily halt antegrade flow. The protocol comprised 5 cycles of 30-s balloon inflations and 30-s deflations.
Direct Ischemic Conditioning BProcedure or surgery
Direct Ischemic Conditioning initiated within 5 minutes post-revascularization using either a balloon guiding catheter or a balloon catheter, positioned at the C1 segment of the ipsilateral internal carotid artery (ICA) to temporarily halt antegrade flow. The protocol comprised 4 cycles of 60-s balloon inflations and 60-s deflations.
Direct Ischemic Conditioning CProcedure or surgery
Direct Ischemic Conditioning initiated within 5 minutes post-revascularization using either a balloon guiding catheter or a balloon catheter, positioned at the C1 segment of the ipsilateral internal carotid artery (ICA) to temporarily halt antegrade flow. The protocol comprised 3 cycles of 120-s balloon inflations and 120-s deflations.
| Study group | Role | What they receive |
|---|---|---|
| Direct Ischemic Conditioning Group A | Experimental | The protocol comprised 5 cycles of 30-s balloon inflations and 30-s deflations. Receives: Procedure: Direct Ischemic Conditioning A |
| Direct Ischemic Conditioning Group B | Experimental | The protocol comprised 4 cycles of 60-s balloon inflations and 60-s deflations. Receives: Procedure: Direct Ischemic Conditioning B |
| Direct Ischemic Conditioning Group C | Experimental | The protocol comprised 3 cycles of 120-s balloon inflations and 120-s deflations. Receives: Procedure: Direct Ischemic Conditioning C |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with modified Rankin Score (mRS) 0 to 2
mRS ranges from 0-6, higher scores mean a worse outcome
Measured: at 90±7 days
Secondary outcomes (14)
distribution of modified Rankin Score (mRS)
mRS ranges from 0-6, higher scores mean a worse outcome
Measured: at 90±7 days
Proportion of patients with modified Rankin Score (mRS) 0 to 1
mRS ranges from 0-6, higher scores mean a worse outcome
Measured: at 90±7 days
Proportion of early neurological improvement
early neurological improvement was defined as a 4 point or greater decrease in National Institute of Health stroke scale (NIHSS). NIHSS range from 0-42, higher scores mean a worse outcome
Measured: at 24 (-6/+24) hours
Change in National Institute of Health stroke scale (NIHSS) score
NIHSS range from 0-42, higher scores mean a worse outcome
Measured: at 24 (-6/+24) hours
Change in National Institute of Health stroke scale (NIHSS) score
NIHSS range from 0-42, higher scores mean a worse outcome
Measured: at 10±2 days
The amount of contrast exudation after treatment (CT assessment)
Measured: at 24 (-6/+24) hours
The amount of midline shift of the brain on neuroimaging after treatmet
Measured: at 24 (-6/+24) hours
Changes in brain circulation time after treatment (between healthy side and affected side, before and after treatment of affected side ischemia)
Measured: immediately after treatment
Recurrent stroke and new cardiovascular and cerebrovascular events
Measured: at 90±7 days
Proportion of balloon treatment-related complications (responsible vessel re-occlusion, vagal reflex, dissection, plaque shedding, and vasospasm during and after treatment)
Measured: immediately after treatment
Proportion of symptomatic intracranial hemorrhage
Measured: at 24 (-6/+24) hours
Proportion of occurrence of cerebral parenchymal hemorrhage types (PH1) and (PH2)
Measured: at 24 (-6/+24) hours
Proportion of serious adverse events
Measured: at 24 (-6/+24) hours
Proportion of all-cause deaths
Measured: at 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start31 Mar 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940128
- Sponsor's protocol ID
- Y(2025)096
- Acronym
- DICER-aLVO
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Ischemic Conditioning for Endovascular Recanalization for Anterior Large Vessel Occlusion (DICER-aLVO): a Prospective, Randomized, Open Label, Blinded-end Point, Phase 2, Multi-centre Study
- ClinicalTrials.gov ID
- NCT06940128
- Acronym / sponsor ID
- DICER-aLVO / Y(2025)096
- Conditions
- Ischemic Stroke
- Keywords
- Direct Ischemic Conditioning, stroke, Endovascular Recanalization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 23 Apr 2025 (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.
Acute ischemic stroke (AIS) is the most common type of stroke, with high incidence rate and mortality. Endovascular therapy is currently the most effective treatment for AIS with large vessel occlusion, but only about 50% of patients achieve good outcome after endovascular therapy, while 50% of patients have poor prognosis, commonly referred to as ineffective perfusion. Therefore, how to improve ineffective perfusion is currently a hot topic.
Numerous studies have shown that Remote Ischemic Therapy (RIC) has a protective effect on ischemic stroke. Our recent RICAMIS study has demonstrated that RIC can significantly improve the functional prognosis of moderate acute ischemic stroke. Furthermore, direct ischemic conditioning has also showed neuroprotective effect. For example, in a rat model, within 2 minutes after reperfusion, using three cycles of 30 s reperfusion and 10 s occlusion for direct ischemic conditioning can effectively alleviate hyperperfusion and reduce cerebral infarction volume. Meanwhile, in previous clinical exploration studies, it was found that even induction by 5-minute ischemia and 5-minute reperfusion for up to 4 cycles is safe, feasible, and well tolerated for AIS patients receiving endovascular treatment. Immediate control of bilateral carotid artery blood flow after ischemia-reperfusion can significantly reduce cerebral infarction area and brain edema, and improve neurological function recovery in rats. Subsequent molecular mechanism studies have shown that direct ischemic conditioning can reduce the production of free radicals after cerebral ischemia-reperfusion, inhibit inflammatory reactions and cell apoptosis, downregulate the expression of signaling molecules mediating brain edema, promote Akt survival pathway, and improve the integrity of the blood-brain barrier, thereby exerting neuroprotective effects. Recent studies have also confirmed the safety and feasibility of direct ischemic conditioning for stroke patients achieving successful recanalization. More importantly, a recent cohort study has shown that direct ischemic conditioning can reduce infarct growth and brain edema after reperfusion in patients with AIS who have undergone thrombectomy for occlusion of large blood vessels in the anterior circulation, and improve prognosis after 90 days.
Based on the above discussion, this trial aims to evaluate the effectiveness and safety of direct ischemic conditioning for patients with AIS who have undergone thrombectomy for occlusion of large blood vessels in the anterior circulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Direct Ischemic Conditioning Group A | Experimental | Procedure: Direct Ischemic Conditioning AThe protocol comprised 5 cycles of 30-s balloon inflations and 30-s deflations. |
| Direct Ischemic Conditioning Group B | Experimental | Procedure: Direct Ischemic Conditioning BThe protocol comprised 4 cycles of 60-s balloon inflations and 60-s deflations. |
| Direct Ischemic Conditioning Group C | Experimental | Procedure: Direct Ischemic Conditioning CThe protocol comprised 3 cycles of 120-s balloon inflations and 120-s deflations. |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -1. Over 18 years old; 2. The time from onset to randomization is less than 24 hours; 3. Patients with acute anterior artery occlusion and receiving successful recanalization (mTICI 2b-3) after endovascular treatment and with residual stenosis ≤ 50%; 4. Cerebral circulation time after successful recanalization: affected side ≤ healthy side; 5. PH2 hemorrhage was excluded by immediate postoperative CT examination; 6. Re-onset patients with first onset or past onset without sequelae such as limb paralysis should not affect the score of this NIHSS, and mRS Score of patients with past onset should be less than 2 points; 7. Signed informed consent by patient or their legally authorized representative.
Key exclusion criteria (2 listed)
- 1. Spherical enlargement of the lesion site twice or more; 2. Proximal residual stenosis >50% for patients with tandem lesions; 3. Intracranial hemorrhagic diseases: cerebral hemorrhage, subarachnoid hemorrhage, etc.
- 4. Chronic liver disease, liver and kidney insufficiency, elevated ALT or AST (greater than 2 times the upper limit of normal), elevated serum creatinine (greater than 1.5 times the upper limit of normal) or dependent on kidney dialysis; 5. Women who are pregnant, have a pregnancy plan or are breastfeeding; 6. Combined with serious other diseases, life expectancy < 6 months; 7. Other conditions deemed inappropriate for participation in this study.
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 |
|---|---|---|
| Direct Ischemic Conditioning ADirect Ischemic Conditioning initiated within 5 minutes post-revascularization using either a balloon guiding catheter or a balloon catheter, positioned at the C1 segment of the ipsilateral internal carotid artery (ICA) to temporarily halt antegrade flow. The protocol comprised 5 cycles of 30-s balloon inflations and 30-s deflations. | Procedure or surgery | Direct Ischemic Conditioning Group A |
| Direct Ischemic Conditioning BDirect Ischemic Conditioning initiated within 5 minutes post-revascularization using either a balloon guiding catheter or a balloon catheter, positioned at the C1 segment of the ipsilateral internal carotid artery (ICA) to temporarily halt antegrade flow. The protocol comprised 4 cycles of 60-s balloon inflations and 60-s deflations. | Procedure or surgery | Direct Ischemic Conditioning Group B |
| Direct Ischemic Conditioning CDirect Ischemic Conditioning initiated within 5 minutes post-revascularization using either a balloon guiding catheter or a balloon catheter, positioned at the C1 segment of the ipsilateral internal carotid artery (ICA) to temporarily halt antegrade flow. The protocol comprised 3 cycles of 120-s balloon inflations and 120-s deflations. | Procedure or surgery | Direct Ischemic Conditioning Group C |
Primary outcome
Proportion of patients with modified Rankin Score (mRS) 0 to 2
Time frame: at 90±7 days
mRS ranges from 0-6, higher scores mean a worse outcome
14 secondary outcomes
distribution of modified Rankin Score (mRS)
Time frame: at 90±7 days
Proportion of patients with modified Rankin Score (mRS) 0 to 1
Time frame: at 90±7 days
Proportion of early neurological improvement
Time frame: at 24 (-6/+24) hours
Change in National Institute of Health stroke scale (NIHSS) score
Time frame: at 24 (-6/+24) hours
Change in National Institute of Health stroke scale (NIHSS) score
Time frame: at 10±2 days
The amount of contrast exudation after treatment (CT assessment)
Time frame: at 24 (-6/+24) hours
The amount of midline shift of the brain on neuroimaging after treatmet
Time frame: at 24 (-6/+24) hours
Changes in brain circulation time after treatment (between healthy side and affected side, before and after treatment of affected side ischemia)
Time frame: immediately after treatment
Recurrent stroke and new cardiovascular and cerebrovascular events
Time frame: at 90±7 days
Proportion of balloon treatment-related complications (responsible vessel re-occlusion, vagal reflex, dissection, plaque shedding, and vasospasm during and after treatment)
Time frame: immediately after treatment
Proportion of symptomatic intracranial hemorrhage
Time frame: at 24 (-6/+24) hours
Proportion of occurrence of cerebral parenchymal hemorrhage types (PH1) and (PH2)
Time frame: at 24 (-6/+24) hours
Proportion of serious adverse events
Time frame: at 24 (-6/+24) hours
Proportion of all-cause deaths
Time frame: at 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Ischemic Conditioning A, Direct Ischemic Conditioning B and Direct Ischemic Conditioning C in people with Ischemic Stroke, run by General Hospital of Shenyang Military Region 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 27 Apr 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui-Sheng Chen (+86-024-28897511, chszh@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with modified Rankin Score (mRS) 0 to 2 (time frame: at 90±7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2026.