Acute Ischemic StrokeANGEL-REBOOTNCT05122286
Randomized Study of Bailout Intracranial Angioplasty Following Thrombectomy for Acute Large Vessel Occlusion
A study testing Bailout angioplasty and Standard therapy in people with Acute Ischemic Stroke, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Unfavorable outcomes were associated with failed thrombectomy of acute large vessel occlusions (LVO). The failed thrombectomy rate was 12-41% reported in multiple randomized controlled trials (RCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Bailout angioplasty and Standard therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2021to 20 Aug 2023
- Phase
- Interventional
- 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
- Clinical Inclusion criteria
- Age ≥18 years
- Pre-stroke mRS 0~2
- Acute ischemic stroke (NIHSS ≥ 6)
- Time-last-known-well to puncture ≤ 24 hours
- Informed consent
Show all 13Show fewer
- Baseline Imaging Inclusion Criteria
- 1.Anterior circulation stroke: CT or DWI ASPECTS ≥ 6; Posterior circulation stroke: CT or DWI pc-ASPECTS ≥ 6 and Pons-Midbrain Index (PMI)<3
- Angiographic Inclusion Criteria
- Acute ischemic stroke caused by LVO, including intracranial internal cerebral artery (ICA), M1 of the middle cerebral artery (MCA), V4 of vertebral artery (VA) or basilar artery (BA)
- Failed recanalization (eTICI 0-2a) or residual severe stenosis (> 70%) after 1-3 attempts of thrombectomy with stent retriever and/or contact aspiration
- Microcatheter can pass through the occluded segment before randomization
- Occluded artery amenable to angioplasty by judgement of the treating neurointerventionalist
Who cannot join
- Any sign of intracranial hemorrhage on brain imaging prior to thrombectomy
- CT or MRI evidence of mass effect or intracranial tumor
- Any sign of intracranial vessel perforation during mechanical thrombectomy prior to randomization
- Contraindication of anti-platelet treatment
- History of contraindication for contrast medium
- Current use of oral anticoagulants (e.g. INR > 1.7 for Vitamin K antagonists)
Show all 11Show fewer
- Current pregnant or breast-feeding
- Known to have dementia or psychiatric disease unable to complete neurological assessment and follow-up
- Life expectancy is less than 3 months
- Enrolled in another drug or device trial or expected to participate in another drug or device treatment trial within the following 3 months.
- Any other condition (in the opinion of the site investigator) that inappropriate to participate this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Study of Bailout Intracranial Angioplasty Following Thrombectomy for Acute Large Vessel Occlusion: A Multi-centered, Prospective, Open-label, Blind Endpoint, Randomized Controlled Trial (ANGEL-REBOOT)
Unfavorable outcomes were associated with failed thrombectomy of acute large vessel occlusions (LVO). The failed thrombectomy rate was 12-41% reported in multiple randomized controlled trials (RCT). Possible reasons of failed thrombectomy included technical failure of access, failure of retrieving thrombus, thrombotic re-occlusion, and pre-existing intracranial atherosclerotic stenosis (ICAS). Several studies have been published on balloon dilation or permanent stenting as rescue approaches for failed thrombectomy in individual cases, but there is no evidence from RCTs regarding this topic. ANGEL-REBOOT aims to close this gap by performing a randomized study of bailout intracranial angioplasty (balloon dilation and/or stenting) for unsuccessful thrombectomy in LVO patients.
Read the detailed description
The ANGEL-REBOOT is a multicentered, prospective, randomized, open-label, blinded end-point (PROBE design) study. A total of approximately 348 patients within 24 hours of symptom onset of acute ischemic stroke (NIHSS≥6), who has the imaging evidence of anterior circulation stroke (CT or DWI ASPECTS≥6) or posterior circulation stroke (CT or DWI pc-ASPECTS≥6 and Pons-Midbrain Index [PMI]<3) caused by an occlusion of intracranial internal cerebral artery (ICA), M1 segment of middle cerebral artery (MCA), V4 segment of vertebral artery (VA) or basilar artery (BA).
Randomization would take place after failed thrombectomy (defined as eTICI 0-2a or a remaining high-grade stenosis > 70% after 1-3 attempts of thrombectomy with stent retriever and/or contact aspiration). Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups (bailout angioplasty or standard therapy) after offering informed content.
If the patient is randomized into the bailout angioplasty arm, the choice of balloon dilation or stenting will be left to the discretion of the interventionalist. If the patient is randomized into the standard therapy arm, the interventionalist will decide whether to stop the endovascular recanalization procedure or to perform further recanalization attempts using stent-retrievers and/or aspiration catheters.
The primary objective is to compare the efficacy and safety of bailout intracranial angioplasty with standard therapy following unsuccessful thrombectomy in acute LVO patients.
The study consists of three visits including 24 hours, 7 days or discharge, and 90 days after randomization. Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment and neurological function scale will be recorded during the study. The primary endpoint is the modified Ranking Scale (mRS) at 90 days. The study is anticipated to last from December 2021 to September 2023 with 348 participants recruited form about 40 centers in China. All the related investigative organization and individuals will obey the Declaration of Helsinki and regulation of Chinese Good Clinical Practice. A scheduled Data and Safety Monitoring Board (DSMB) meeting will oversight the safety and data quality of the study. The trial has been approved by Institutional Review Board (IRB) and Ethics Committee (EC) in Beijing Tiantan hospital, Capital Medical University.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Bailout angioplasty, Standard therapy
- Keywords
- Endovascular treatment, Large vessel occlusion, Angioplasty, Thrombectomy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bailout angioplastyProcedure or surgery
Use balloons or stents for bailout angioplasty
Standard therapyProcedure or surgery
Stop the endovascular recanalization procedure or to perform further recanalization attempts using stent-retrievers and/or aspiration catheters
| Study group | Role | What they receive |
|---|---|---|
| Bailout angioplasty | Experimental | If the patient is randomized into the bailout angioplasty arm, the choice of balloon dilation or stenting will be left to the discretion of the interventionalist. Receives: Procedure: Bailout angioplasty |
| Standard therapy | Active comparator | If the patient is randomized into the standard therapy arm, the interventionalist will decide whether to stop the endovascular recanalization procedure or to perform further recanalization attempts using stent-retrievers and/or aspiration catheters. Receives: Procedure: Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome 90 (±14) days after randomization on the modified Ranking Score (mRS) as an ordinal scale (shift analysis)
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.
Score 0: No symptoms. Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms.
Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
Score 6: Dead
Measured: 90±14 days after randomization
Secondary outcomes (13)
Rate of good functional outcome (mRS 0-2) at 90 (±14) days after randomization
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.
Score 0: No symptoms. Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms.
Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
Score 6: Dead
Measured: 90±14 days after randomization
Rate of independent ambulation (mRS 0-3) at 90 (±14) days after randomization
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.
Score 0: No symptoms. Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms.
Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
Score 6: Dead
Measured: 90±14 days after randomization
Functional health status and quality of life (EQ-5D-5L) at 90 (±14) days after randomization
EQ-5D-5L is a standardized instrument for measuring the general health status. Rated level can be coded as a number 1, 2, 3, 4 or 5, which indicates having no problems for 1, having some problems for 2, having moderate problems for 3, having serious problems for 4 and having extreme problems for 5.
Measured: 90±14 days after randomization
Technical success defined as successful recanalization (eTICI 2b-3) of the occluded vessel at the end of the procedure
In brief, eTICI grade 0 is equivalent to no reperfusion or 0% filling of the downstream territory; eTICI 1 reflects thrombus reduction without any reperfusion of distal arteries; eTICI 2a is reperfusion in less than half or 1-49% of the territory; eTICI 2b50 is 50-66% reperfusion, exceeding the modified TICI (mTICI) 2B threshold but below the original TICI 2B cut-off point; eTICI 2b67 is 67-89% reperfusion, exceeding TICI but below TICI 2C; eTICI 2c is equivalent to TICI 2C or 90-99% reperfusion; and eTICI 3 is complete or 100% reperfusion, tantamount to TICI 3.
Measured: The end of the procedure
Infarct volume on FLAIR/T2WI or CT after 18-36 hours of randomization
The infarct volume is determined on FLAIR or T2-weighted MRI (preferred) or CT if MRI is not feasible.
Measured: 18-36 hours after randomization
NIHSS score at 24 hours after randomization
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The single patient assessment requires less than 10 minutes to complete. The evaluation of stroke severity depends upon the ability of the observer to accurately and consistently assess the patient.
Measured: 24 hours after randomization
Proportion of target vessel recanalization at 18-36 hours after randomization
Target vessel recanalization defined as grade 2-3 of arterial occlusive lesion (AOL) scale.
Definition of AOL grades:
Grade 0--Complete occlusion of the target artery; Grade 1--Incomplete occlusion or partial local recanalization at the target artery with no distal flow; Grade 2--Incomplete occlusion or partial local recanalization at the target artery with any distal flow; Grade 3--Complete recanalization and restoration of the target artery with any distal flow.
Measured: 18-36 hours after randomization
Symptomatic intracranial hemorrhage (SICH) defined as the Heidelberg classification within 18-36 hours of randomization
Heidelberg standard was defined as new intracranial hemorrhage detected by brain imaging associated with any of the item below:
- 4 points total NIHSS at the time of diagnosis compared to immediately before worsening.
- 2 point in one NIHSS category. Leading to intubation/hemicraniectomy/ventricular drainage placement or other major medical/surgical intervention.
- Absence of alternative explanation for deterioration.
Measured: 18-36 hours after randomization
Severe procedure-related complications (e.g. dissection of intracranial artery)
Severe procedure-related complications (e.g. dissection of intracranial artery)
Measured: 90±14 days after randomization
Recurrence of ischemic stroke in downstream territory of the occluded vessel within 90 (±14) days after randomization
Recurrence of ischemic stroke in downstream territory of the occluded vessel within 90 (±14) days after randomization
Measured: 90±14 days after randomization
Parenchymal hemorrhage type 2 (PH-2) after 18-36 hours of randomization
Parenchymal hemorrhage type 2 (PH-2) after 18-36 hours of randomization
Measured: 18-36 hours after randomization
Infarct in new territories (INT) within 18-36 hours of randomization
INT is classified based on two parameters: size (types I, II, and III) and catheter manipulation across territory ostium (types A and B). Thus an INT may be classified as IA, IIB, etc.
Classification of INT based on size:
Type I: ≤2 mm diffusion lesion (unidentifiable on CT scan). Type II: >2 mm to ≤20 mm lesion (could potentially be difficult to identify on CT scan).
Type III: Large (>20 mm) infarct in new territory.
Classification of INT based on catheter manipulation across territory ostium:
Type A: Catheter was manipulated past the ostium of the new territory (eg, large ACA infarct in a patient who originally had an M1 occlusion): increased likelihood infarct is related to procedure.
Type B: Catheter was not manipulated past the ostium of the new territory (eg, left PICA infarct in a patient who originally had a right M1 occlusion): decreased likelihood infarct is related to procedure.
Measured: 18-36 hours after randomization
Mortality within 90 (±14) days after randomization
Mortality within 90 (±14) days after randomization
Measured: 90±14 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start19 Dec 2021
- Primary completion2 Jun 2023
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongrong Miao, Beijing Tiantan Hospital
- Investigators
- Zhongrong Miao, MD, Principal investigator, Beijing Tiantan HospitalFeng Gao, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122286
- Sponsor's protocol ID
- HA-X-026(2020)
- Acronym
- ANGEL-REBOOT
- Status last verified
- Aug 2023
- First submitted
- 25 Sep 2021
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gao F, Tong X, Wei M, Yao X, Li L, Pan Y, Jia B, Nguyen TN, Yang M, Sun D, Feng G, Yuan G, Xu C, Yuan Z, Wan Y, Wang J, Jing P, Yang X, Wu Z, Hu W, Jiang Y, Wang C, Wen C, Tang J, Luo X, Wu Y, Shen R, Zheng T, Sun Y, Chang M, Liu Y, Haihua Y, Li D, Yin B, Jia W, Wan D, Xu G, Guo Z, Sun D, Wang Y, Duan J, Wang L, Wang G, Wei L, Ma G, Huo X, Mo D, Ma N, Ren Z, Liu L, Zhao X, Wang Y, Fiehler J, Wang Y, Miao Z; ANGEL-REBOOT Study Group. Bailout Intracranial Angioplasty or Stenting After Thrombectomy for Acute Large Vessel Occlusion: 1-Year Outcomes of ANGEL-REBOOT. Circulation. 2025 Nov 18;152(20):1397-1407. doi: 10.1161/CIRCULATIONAHA.125.075429. Epub 2025 Oct 22.
PubMed 41122847Li L, Song S, Mo D, Tong X, Miao Z, Gao F; ANGEL-REBOOT Study Group. Factors Associated With Early Reocclusion in Recanalized Intracranial Atherosclerotic Occlusion: ANGEL-REBOOT Insights. Stroke. 2025 Sep;56(9):2431-2439. doi: 10.1161/STROKEAHA.125.051789. Epub 2025 Jun 9.
PubMed 40485466Gao F, Tong X, Jia B, Wei M, Pan Y, Yang M, Sun D, Nguyen TN, Ren Z, Demiraj F, Yao X, Xu C, Yuan G, Wan Y, Tang J, Wang J, Jiang Y, Wang C, Luo X, Yang H, Shen R, Wu Z, Yuan Z, Wan D, Hu W, Liu Y, Jing P, Wei L, Zheng T, Wu Y, Yang X, Sun Y, Wen C, Chang M, Yin B, Li D, Duan J, Sun D, Guo Z, Xu G, Wang G, Wang L, Wang Y, Jia W, Ma G, Huo X, Mo D, Ma N, Liu L, Zhao X, Wang Y, Fiehler J, Wang Y, Miao Z. Bailout intracranial angioplasty or stenting following thrombectomy for acute large vessel occlusion in China (ANGEL-REBOOT): a multicentre, open-label, blinded-endpoint, randomised controlled trial. Lancet Neurol. 2024 Aug;23(8):797-806. doi: 10.1016/S1474-4422(24)00186-8. Epub 2024 Jun 21.
PubMed 38914085Gao F, Tong X, Jia B, Yang M, Pan Y, Ren Z, Burgin WS, Liu L, Zhao X, Wang Y, Wang Y, Miao Z. Randomised study of bailout intracranial angioplasty following thrombectomy for acute large vessel occlusion (ANGEL-REBOOT): protocol of a multicentre randomised controlled trial. Stroke Vasc Neurol. 2024 Apr 30;9(2):181-188. doi: 10.1136/svn-2023-002433.
PubMed 37474136
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Bailout Intracranial Angioplasty Following Thrombectomy for Acute Large Vessel Occlusion: A Multi-centered, Prospective, Open-label, Blind Endpoint, Randomized Controlled Trial (ANGEL-REBOOT)
- ClinicalTrials.gov ID
- NCT05122286
- Acronym / sponsor ID
- ANGEL-REBOOT / HA-X-026(2020)
- Conditions
- Acute Ischemic Stroke
- Keywords
- Endovascular treatment, Large vessel occlusion, Angioplasty, Thrombectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 19 Dec 2021 (actual)
- Primary completion
- 2 Jun 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 16 Nov 2021 (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.
Unfavorable outcomes were associated with failed thrombectomy of acute large vessel occlusions (LVO). The failed thrombectomy rate was 12-41% reported in multiple randomized controlled trials (RCT). Possible reasons of failed thrombectomy included technical failure of access, failure of retrieving thrombus, thrombotic re-occlusion, and pre-existing intracranial atherosclerotic stenosis (ICAS). Several studies have been published on balloon dilation or permanent stenting as rescue approaches for failed thrombectomy in individual cases, but there is no evidence from RCTs regarding this topic. ANGEL-REBOOT aims to close this gap by performing a randomized study of bailout intracranial angioplasty (balloon dilation and/or stenting) for unsuccessful thrombectomy in LVO patients.
Detailed description
The ANGEL-REBOOT is a multicentered, prospective, randomized, open-label, blinded end-point (PROBE design) study. A total of approximately 348 patients within 24 hours of symptom onset of acute ischemic stroke (NIHSS≥6), who has the imaging evidence of anterior circulation stroke (CT or DWI ASPECTS≥6) or posterior circulation stroke (CT or DWI pc-ASPECTS≥6 and Pons-Midbrain Index [PMI]<3) caused by an occlusion of intracranial internal cerebral artery (ICA), M1 segment of middle cerebral artery (MCA), V4 segment of vertebral artery (VA) or basilar artery (BA).
Randomization would take place after failed thrombectomy (defined as eTICI 0-2a or a remaining high-grade stenosis > 70% after 1-3 attempts of thrombectomy with stent retriever and/or contact aspiration). Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups (bailout angioplasty or standard therapy) after offering informed content.
If the patient is randomized into the bailout angioplasty arm, the choice of balloon dilation or stenting will be left to the discretion of the interventionalist. If the patient is randomized into the standard therapy arm, the interventionalist will decide whether to stop the endovascular recanalization procedure or to perform further recanalization attempts using stent-retrievers and/or aspiration catheters.
The primary objective is to compare the efficacy and safety of bailout intracranial angioplasty with standard therapy following unsuccessful thrombectomy in acute LVO patients.
The study consists of three visits including 24 hours, 7 days or discharge, and 90 days after randomization. Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment and neurological function scale will be recorded during the study. The primary endpoint is the modified Ranking Scale (mRS) at 90 days. The study is anticipated to last from December 2021 to September 2023 with 348 participants recruited form about 40 centers in China. All the related investigative organization and individuals will obey the Declaration of Helsinki and regulation of Chinese Good Clinical Practice. A scheduled Data and Safety Monitoring Board (DSMB) meeting will oversight the safety and data quality of the study. The trial has been approved by Institutional Review Board (IRB) and Ethics Committee (EC) in Beijing Tiantan hospital, Capital Medical University.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bailout angioplasty | Experimental | Procedure: Bailout angioplastyIf the patient is randomized into the bailout angioplasty arm, the choice of balloon dilation or stenting will be left to the discretion of the interventionalist. |
| Standard therapy | Active comparator | Procedure: Standard therapyIf the patient is randomized into the standard therapy arm, the interventionalist will decide whether to stop the endovascular recanalization procedure or to perform further recanalization attempts using stent-retrievers and/or aspiration catheters. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Clinical Inclusion criteria
- Baseline Imaging Inclusion Criteria
- 1.Anterior circulation stroke: CT or DWI ASPECTS ≥ 6; Posterior circulation stroke: CT or DWI pc-ASPECTS ≥ 6 and Pons-Midbrain Index (PMI)<3
- Angiographic Inclusion Criteria
Key exclusion criteria (11 listed)
- Any sign of intracranial hemorrhage on brain imaging prior to thrombectomy
- CT or MRI evidence of mass effect or intracranial tumor
- Any sign of intracranial vessel perforation during mechanical thrombectomy prior to randomization
- Contraindication of anti-platelet treatment
- History of contraindication for contrast medium
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 |
|---|---|---|
| Bailout angioplastyUse balloons or stents for bailout angioplasty | Procedure or surgery | Bailout angioplasty |
| Standard therapyStop the endovascular recanalization procedure or to perform further recanalization attempts using stent-retrievers and/or aspiration catheters | Procedure or surgery | Standard therapy |
Primary outcome
Clinical outcome 90 (±14) days after randomization on the modified Ranking Score (mRS) as an ordinal scale (shift analysis)
Time frame: 90±14 days after randomization
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. Score 0: No symptoms. Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms. Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Score 6: Dead
13 secondary outcomes
Rate of good functional outcome (mRS 0-2) at 90 (±14) days after randomization
Time frame: 90±14 days after randomization
Rate of independent ambulation (mRS 0-3) at 90 (±14) days after randomization
Time frame: 90±14 days after randomization
Functional health status and quality of life (EQ-5D-5L) at 90 (±14) days after randomization
Time frame: 90±14 days after randomization
Technical success defined as successful recanalization (eTICI 2b-3) of the occluded vessel at the end of the procedure
Time frame: The end of the procedure
Infarct volume on FLAIR/T2WI or CT after 18-36 hours of randomization
Time frame: 18-36 hours after randomization
NIHSS score at 24 hours after randomization
Time frame: 24 hours after randomization
Proportion of target vessel recanalization at 18-36 hours after randomization
Time frame: 18-36 hours after randomization
Symptomatic intracranial hemorrhage (SICH) defined as the Heidelberg classification within 18-36 hours of randomization
Time frame: 18-36 hours after randomization
Severe procedure-related complications (e.g. dissection of intracranial artery)
Time frame: 90±14 days after randomization
Recurrence of ischemic stroke in downstream territory of the occluded vessel within 90 (±14) days after randomization
Time frame: 90±14 days after randomization
Parenchymal hemorrhage type 2 (PH-2) after 18-36 hours of randomization
Time frame: 18-36 hours after randomization
Infarct in new territories (INT) within 18-36 hours of randomization
Time frame: 18-36 hours after randomization
Mortality within 90 (±14) days after randomization
Time frame: 90±14 days after randomization
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 22 Aug 2023.
- Derived from this study: PubMed 41122847Gao F, Tong X, Wei M, Yao X, Li L, Pan Y, Jia B, Nguyen TN, Yang M, Sun D, Feng G, Yuan G, Xu C, Yuan Z, Wan Y, Wang J, Jing P, Yang X, Wu Z, Hu W, Jiang Y, Wang C, Wen C, Tang J, Luo X, Wu Y, Shen R, Zheng T, Sun Y, Chang M, Liu Y, Haihua Y, Li D, Yin B, Jia W, Wan D, Xu G, Guo Z, Sun D, Wang Y, Duan J, Wang L, Wang G, Wei L, Ma G, Huo X, Mo D, Ma N, Ren Z, Liu L, Zhao X, Wang Y, Fiehler J, Wang Y, Miao Z; ANGEL-REBOOT Study Group. Bailout Intracranial Angioplasty or Stenting After Thrombectomy for Acute Large Vessel Occlusion: 1-Year Outcomes of ANGEL-REBOOT. Circulation. 2025 Nov 18;152(20):1397-1407. doi: 10.1161/CIRCULATIONAHA.125.075429. Epub 2025 Oct 22.
- Derived from this study: PubMed 40485466Li L, Song S, Mo D, Tong X, Miao Z, Gao F; ANGEL-REBOOT Study Group. Factors Associated With Early Reocclusion in Recanalized Intracranial Atherosclerotic Occlusion: ANGEL-REBOOT Insights. Stroke. 2025 Sep;56(9):2431-2439. doi: 10.1161/STROKEAHA.125.051789. Epub 2025 Jun 9.
- Derived from this study: PubMed 38914085Gao F, Tong X, Jia B, Wei M, Pan Y, Yang M, Sun D, Nguyen TN, Ren Z, Demiraj F, Yao X, Xu C, Yuan G, Wan Y, Tang J, Wang J, Jiang Y, Wang C, Luo X, Yang H, Shen R, Wu Z, Yuan Z, Wan D, Hu W, Liu Y, Jing P, Wei L, Zheng T, Wu Y, Yang X, Sun Y, Wen C, Chang M, Yin B, Li D, Duan J, Sun D, Guo Z, Xu G, Wang G, Wang L, Wang Y, Jia W, Ma G, Huo X, Mo D, Ma N, Liu L, Zhao X, Wang Y, Fiehler J, Wang Y, Miao Z. Bailout intracranial angioplasty or stenting following thrombectomy for acute large vessel occlusion in China (ANGEL-REBOOT): a multicentre, open-label, blinded-endpoint, randomised controlled trial. Lancet Neurol. 2024 Aug;23(8):797-806. doi: 10.1016/S1474-4422(24)00186-8. Epub 2024 Jun 21.
- Derived from this study: PubMed 37474136Gao F, Tong X, Jia B, Yang M, Pan Y, Ren Z, Burgin WS, Liu L, Zhao X, Wang Y, Wang Y, Miao Z. Randomised study of bailout intracranial angioplasty following thrombectomy for acute large vessel occlusion (ANGEL-REBOOT): protocol of a multicentre randomised controlled trial. Stroke Vasc Neurol. 2024 Apr 30;9(2):181-188. doi: 10.1136/svn-2023-002433.
Related trials for Acute Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
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.
Zhongrong Miao, MD principal investigator
Beijing Tiantan Hospital
Feng Gao, MD principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bailout angioplasty and Standard therapy in people with Acute Ischemic Stroke, run by Beijing Tiantan Hospital 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 13 inclusion and 11 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 22 Aug 2023. 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?
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?
Clinical outcome 90 (±14) days after randomization on the modified Ranking Score (mRS) as an ordinal scale (shift analysis) (time frame: 90±14 days after randomization). 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 NCT05122286, which also lists 4 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 22 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.