Acute Ischemic StrokeANGEL-ICASNCT07026331
Effect of Balloon Angioplasty vs Stenting Following Residual Stenosis After Endovascular Treatment of Intracranial Atherosclerotic Acute Ischemic Stroke
A study testing balloon angioplasty and Stent in people with Acute Ischemic Stroke and Intracranial Atherosclerosis ICAS, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
The ANGEL-ICAS trial is a multicenter, prospective, randomized, open-label, blinded-endpoint study designed to determine whether rescue balloon angioplasty is noninferior to rescue stenting in patients with intracranial atherosclerosis-related acute ischemic stroke who have residual intracranial arterial stenosis of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Intracranial Atherosclerosis ICAS
- What is being tested?
- balloon angioplasty and Stent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 486 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2025to 1 Jul 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
- Age 18 years or older.
- Pre-stroke modified Rankin Scale (mRS) score of 0-1.
- Symptoms of acute ischemic stroke presenting within 24 hours of the last known well time.
- Baseline National Institutes of Health Stroke Scale (NIHSS) score of at least 6.
- Baseline Alberta Stroke Program Early CT Score (ASPECTS) of at least 6 for anterior-circulation stroke, or posterior-circulation ASPECTS (pc-ASPECTS) of at least 6 for posterior-circulation stroke.
- Occlusion of the intracranial internal carotid artery, M1 segment of the middle cerebral artery, V4 segment of the vertebral artery, or basilar artery.
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- The clinical care team plans to perform endovascular treatment.
- The participant or the participant's legally authorized representative is able to provide written informed consent.
- Baseline CT perfusion or MR perfusion imaging demonstrating an ischemic core volume of less than 70 mL, a mismatch ratio of at least 1.2, and a mismatch volume of at least 15 mL.
- Intracranial atherosclerosis is considered the underlying etiology, with residual stenosis of at least 50% after endovascular treatment, and rescue balloon angioplasty or stenting is planned
Who cannot join
- Any intracranial hemorrhage identified on imaging before randomization; or major intracranial hemorrhage, defined as parenchymal hematoma type 1 or type 2, identified on intraprocedural flat-panel CT. Parenchymal hematoma type 1 is defined as blood clots involving less than 30% of the infarcted area, with or without a slight space-occupying effect; parenchymal hematoma type 2 is defined as blood clots involving more than 30% of the infarcted area with a substantial space-occupying effect.
- Gastrointestinal or genitourinary bleeding within 30 days before stroke onset, or major surgery within 14 days before stroke onset.
- Bleeding diathesis, including platelet count below 100 × 10⁹/L, activated partial thromboplastin time greater than 50 seconds, or international normalized ratio greater than 2.0; treatment with a direct oral anticoagulant within the preceding 48 hours; or a history of heparin-induced thrombocytopenia.
- Pregnancy or breastfeeding at admission.
- Contraindication to iodinated contrast agents, nickel, titanium, or their alloys.
- Life expectancy of less than 6 months.
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- Pre-existing neurological or psychiatric disease that may confound neurological or functional outcome assessment.
- Severe renal impairment, defined as glomerular filtration rate below 30 mL/min or serum creatinine above 220 μmol/L (2.5 mg/dL).
- Arterial tortuosity or another arterial condition that would prevent the study device from reaching the target vessel.
- Unlikely to complete the 90-day follow-up.
- Any definite cardioembolic source, including chronic or paroxysmal atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical heart valve, endocarditis, history of atrial or ventricular thrombus, myocardial infarction within the preceding 3 months, dilated cardiomyopathy, spontaneous echo contrast in the left atrium, or left ventricular ejection fraction below 30%.
- Use of any glycoprotein IIb/IIIa inhibitor other than tirofiban.
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
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 101118
Xiaochuan Huo, Doctor, +86 13716292262, hxc810909@163.com
Xin Tong, +86 17810651085, tomice123@foxmail.com
About this study
Official title: Effect of Balloon Angioplasty vs Stenting Following Residual Stenosis After Endovascular Treatment of Intracranial Atherosclerotic Acute Ischemic Stroke: A Multicenter, Prospective, Open-label, Endpoint-blinded, Randomized Controlled Study
The ANGEL-ICAS trial is a multicenter, prospective, randomized, open-label, blinded-endpoint study designed to determine whether rescue balloon angioplasty is noninferior to rescue stenting in patients with intracranial atherosclerosis-related acute ischemic stroke who have residual intracranial arterial stenosis of at least 50% after endovascular treatment and require additional rescue therapy.
A total of 486 eligible participants will be randomly assigned in a 1:1 ratio to the balloon angioplasty group or the stenting group. In the balloon angioplasty group, rescue stenting is permitted if the angiographic result after balloon angioplasty is considered inadequate. In the stenting group, balloon angioplasty may be performed in conjunction with stent implantation when clinically indicated. Both groups will receive standard medical management according to the study protocol.
The primary outcome is the proportion of participants achieving functional independence, defined as a modified Rankin Scale score of 0-2, at 90 days after randomization. Key safety outcomes include symptomatic intracranial hemorrhage within 48 hours, any intracranial hemorrhage within 48 hours, and all-cause mortality at 90 days
- Being tested
- balloon angioplasty, Stent
- Keywords
- Intracranial Atherosclerotic Disease, Large Vessel Occlusion, Residual Intracranial Stenosis, Rescue Balloon Angioplasty, Intracranial Stenting, Endovascular 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.
balloon angioplastyProcedure or surgery
Balloon angioplasty treatment followed by standard medical therapy post-procedure.
StentProcedure or surgery
Patients will receive either balloon-assisted stenting or direct stenting, followed by standard medical therapy after the endovascular treatment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Rescue Balloon Angioplasty Group | Experimental | Participants randomized to this group will undergo intracranial balloon angioplasty as the assigned initial rescue strategy for residual intracranial arterial stenosis after endovascular treatment. Bailout intracranial stenting is permitted if the angiographic result after balloon angioplasty is considered inadequate by the treating neurointerventionist according to the study protocol. Participants will receive periprocedural and postprocedural medical management according to the study protocol. Receives: Procedure: balloon angioplasty |
| Active Comparator: Rescue Intracranial Stenting Group | Active comparator | Participants randomized to this group will undergo intracranial stent implantation as the assigned rescue strategy for residual intracranial arterial stenosis after endovascular treatment. Balloon angioplasty may be performed before or after stent implantation when clinically indicated. Participants will receive periprocedural and postprocedural medical management according to the study protocol. Receives: Procedure: Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with mRS 0-2
Functional independence is defined as a modified Rankin Scale (mRS) score of 0-2. The mRS is an ordinal scale ranging from 0 (no symptoms) to 6 (death), with lower scores indicating better functional outcomes.
Measured: 90 days after randomization (±7 days)
Secondary outcomes (13)
Change in NIHSS Score From Baseline to 36 Hours
The National Institutes of Health Stroke Scale (NIHSS) ranges from 0 to 42, with higher scores indicating greater neurological impairment. Change will be calculated as the NIHSS score at 36 hours minus the baseline NIHSS score; negative values indicate neurological improvement.
Measured: 36 hours after randomization (±12 hours)
Proportion of Participants With Target-Vessel Recanalization at 36 Hours
Target-vessel recanalization will be assessed on CT angiography or MR angiography by the blinded central imaging core laboratory according to the prespecified imaging criterion.
Measured: 36 hours after randomization (±12 hours)
Change in Infarct Volume From Baseline to Day 7 or Discharge
Change in infarct volume will be calculated as the follow-up infarct volume minus the baseline ischemic core volume, measured in milliliters by the blinded central imaging core laboratory using validated automated imaging software. Positive values indicate infarct growth.
Measured: 7 days after randomization (±1 day) or at discharge, whichever occurs first
Distribution of mRS Scores at Day 7 or Discharge
Distribution of modified Rankin Scale scores across all categories from 0 (no symptoms) to 6 (death), with lower scores indicating better functional outcomes.
Measured: 7 days after randomization or at discharge, whichever occurs first
Distribution of mRS Scores at 90 Days
Distribution of modified Rankin Scale scores across all categories from 0 (no symptoms) to 6 (death), with lower scores indicating better functional outcomes.
Measured: 90 days after randomization (±7 days)
Proportion of Participants Achieving an Excellent Functional Outcome at 90 Days
An excellent functional outcome is defined as a modified Rankin Scale score of 0-1. The mRS ranges from 0 (no symptoms) to 6 (death).
Measured: 90 days after randomization (±7 days)
Proportion of Participants With an mRS Score of 0-3 at 90 Days
The outcome is defined as a modified Rankin Scale score of 0-3. The mRS ranges from 0 (no symptoms) to 6 (death), with lower scores indicating better functional outcomes.
Measured: 90 days after randomization (±7 days)
Proportion of Participants Requiring Additional Pharmacologic Rescue Therapy
Proportion of participants who receive additional pharmacologic rescue treatment for target-vessel reocclusion, restenosis, or related clinical deterioration after the randomized intervention. Protocol-mandated routine antiplatelet treatment will not be counted as pharmacologic rescue therapy.
Measured: Within 90 days after randomization
Proportion of Participants Requiring Additional Procedural Rescue Treatment
Proportion of participants who undergo an additional endovascular or surgical rescue procedure because of target-vessel reocclusion, restenosis, or related clinical deterioration after the randomized intervention.
Measured: Within 90 days after randomization
EQ-5D-5L Index Score at 90 Days
Health-related quality of life will be assessed using the EQ-5D-5L index score calculated with the prespecified Chinese value set. Scores range from -0.594 to 1.000, with higher scores indicating better health status.
Measured: 90 days after randomization (±7 days)
Symptomatic Intracranial Hemorrhage Within 48 Hours
Symptomatic intracranial hemorrhage will be classified according to the Heidelberg Bleeding Classification and adjudicated by the blinded central imaging core laboratory and clinical event assessors.
Measured: Within 48 hours after randomization
All-Cause Mortality at 90 Days
Proportion of participants who die from any cause within 90 days after randomization.
Measured: Within 90 days after randomization (assessment window ±7 days)
Any Intracranial Hemorrhage Within 48 Hours
Any intracranial hemorrhage identified on follow-up CT or MRI and classified according to the Heidelberg Bleeding Classification, irrespective of the presence of neurological deterioration.
Measured: Within 48 hours after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start3 Jul 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen 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
- Model description
- Eligible participants will be centrally randomized in a 1:1 ratio to rescue balloon angioplasty or rescue stenting in parallel. Randomization will be performed using a stratified block design, with stratification by participating center and target-vessel occlusion location. The study is designed to evaluate the noninferiority of rescue balloon angioplasty to rescue stenting for the primary outcome.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 486 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026331
- Sponsor's protocol ID
- ANGEL-ICAS
- Acronym
- ANGEL-ICAS
- Status last verified
- Jul 2026
- First submitted
- 3 Jun 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Balloon Angioplasty vs Stenting Following Residual Stenosis After Endovascular Treatment of Intracranial Atherosclerotic Acute Ischemic Stroke: A Multicenter, Prospective, Open-label, Endpoint-blinded, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07026331
- Acronym / sponsor ID
- ANGEL-ICAS / ANGEL-ICAS
- Keywords
- Intracranial Atherosclerotic Disease, Large Vessel Occlusion, Residual Intracranial Stenosis, Rescue Balloon Angioplasty, Intracranial Stenting, Endovascular Thrombectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 486 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 18 Jun 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.
The ANGEL-ICAS trial is a multicenter, prospective, randomized, open-label, blinded-endpoint study designed to determine whether rescue balloon angioplasty is noninferior to rescue stenting in patients with intracranial atherosclerosis-related acute ischemic stroke who have residual intracranial arterial stenosis of at least 50% after endovascular treatment and require additional rescue therapy.
A total of 486 eligible participants will be randomly assigned in a 1:1 ratio to the balloon angioplasty group or the stenting group. In the balloon angioplasty group, rescue stenting is permitted if the angiographic result after balloon angioplasty is considered inadequate. In the stenting group, balloon angioplasty may be performed in conjunction with stent implantation when clinically indicated. Both groups will receive standard medical management according to the study protocol.
The primary outcome is the proportion of participants achieving functional independence, defined as a modified Rankin Scale score of 0-2, at 90 days after randomization. Key safety outcomes include symptomatic intracranial hemorrhage within 48 hours, any intracranial hemorrhage within 48 hours, and all-cause mortality at 90 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible participants will be centrally randomized in a 1:1 ratio to rescue balloon angioplasty or rescue stenting in parallel. Randomization will be performed using a stratified block design, with stratification by participating center and target-vessel occlusion location. The study is designed to evaluate the noninferiority of rescue balloon angioplasty to rescue stenting for the primary outcome.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Rescue Balloon Angioplasty Group | Experimental | Procedure: balloon angioplastyParticipants randomized to this group will undergo intracranial balloon angioplasty as the assigned initial rescue strategy for residual intracranial arterial stenosis after endovascular treatment. Bailout intracranial stenting is permitted if the angiographic result after balloon angioplasty is considered inadequate by the treating neurointerventionist according to the study protocol. Participants will receive periprocedural and postprocedural medical management according to the study protocol. |
| Active Comparator: Rescue Intracranial Stenting Group | Active comparator | Procedure: StentParticipants randomized to this group will undergo intracranial stent implantation as the assigned rescue strategy for residual intracranial arterial stenosis after endovascular treatment. Balloon angioplasty may be performed before or after stent implantation when clinically indicated. Participants will receive periprocedural and postprocedural medical management according to the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 years or older.
- Pre-stroke modified Rankin Scale (mRS) score of 0-1.
- Symptoms of acute ischemic stroke presenting within 24 hours of the last known well time.
- Baseline National Institutes of Health Stroke Scale (NIHSS) score of at least 6.
- Baseline Alberta Stroke Program Early CT Score (ASPECTS) of at least 6 for anterior-circulation stroke, or posterior-circulation ASPECTS (pc-ASPECTS) of at least 6 for posterior-circulation stroke.
Key exclusion criteria (12 listed)
- Any intracranial hemorrhage identified on imaging before randomization; or major intracranial hemorrhage, defined as parenchymal hematoma type 1 or type 2, identified on intraprocedural flat-panel CT. Parenchymal hematoma type 1 is defined as blood clots involving less than 30% of the infarcted area, with or without a slight space-occupying effect; parenchymal hematoma type 2 is defined as blood clots involving more than 30% of the infarcted area with a substantial space-occupying effect.
- Gastrointestinal or genitourinary bleeding within 30 days before stroke onset, or major surgery within 14 days before stroke onset.
- Bleeding diathesis, including platelet count below 100 × 10⁹/L, activated partial thromboplastin time greater than 50 seconds, or international normalized ratio greater than 2.0; treatment with a direct oral anticoagulant within the preceding 48 hours; or a history of heparin-induced thrombocytopenia.
- Pregnancy or breastfeeding at admission.
- Contraindication to iodinated contrast agents, nickel, titanium, or their alloys.
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 |
|---|---|---|
| balloon angioplastyBalloon angioplasty treatment followed by standard medical therapy post-procedure. | Procedure or surgery | Experimental: Rescue Balloon Angioplasty Group |
| StentPatients will receive either balloon-assisted stenting or direct stenting, followed by standard medical therapy after the endovascular treatment. | Procedure or surgery | Active Comparator: Rescue Intracranial Stenting Group |
Primary outcome
Proportion of patients with mRS 0-2
Time frame: 90 days after randomization (±7 days)
Functional independence is defined as a modified Rankin Scale (mRS) score of 0-2. The mRS is an ordinal scale ranging from 0 (no symptoms) to 6 (death), with lower scores indicating better functional outcomes.
13 secondary outcomes
Change in NIHSS Score From Baseline to 36 Hours
Time frame: 36 hours after randomization (±12 hours)
Proportion of Participants With Target-Vessel Recanalization at 36 Hours
Time frame: 36 hours after randomization (±12 hours)
Change in Infarct Volume From Baseline to Day 7 or Discharge
Time frame: 7 days after randomization (±1 day) or at discharge, whichever occurs first
Distribution of mRS Scores at Day 7 or Discharge
Time frame: 7 days after randomization or at discharge, whichever occurs first
Distribution of mRS Scores at 90 Days
Time frame: 90 days after randomization (±7 days)
Proportion of Participants Achieving an Excellent Functional Outcome at 90 Days
Time frame: 90 days after randomization (±7 days)
Proportion of Participants With an mRS Score of 0-3 at 90 Days
Time frame: 90 days after randomization (±7 days)
Proportion of Participants Requiring Additional Pharmacologic Rescue Therapy
Time frame: Within 90 days after randomization
Proportion of Participants Requiring Additional Procedural Rescue Treatment
Time frame: Within 90 days after randomization
EQ-5D-5L Index Score at 90 Days
Time frame: 90 days after randomization (±7 days)
Symptomatic Intracranial Hemorrhage Within 48 Hours
Time frame: Within 48 hours after randomization
All-Cause Mortality at 90 Days
Time frame: Within 90 days after randomization (assessment window ±7 days)
Any Intracranial Hemorrhage Within 48 Hours
Time frame: Within 48 hours after randomization
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 3 Sep 2026.
- Individual participant dataSharing planned: No
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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 balloon angioplasty and Stent in people with Acute Ischemic Stroke and Intracranial Atherosclerosis ICAS, run by Beijing Anzhen 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 10 inclusion and 12 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 3 Sep 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 Xiaochuan Huo, Doctor (+86 13716292262, hxc810909@163.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 mRS 0-2 (time frame: 90 days after randomization (±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 3 Sep 2026.