Efficacy and Safety of Bailout Intracranial Angioplasty or Stenting After Thrombectomy for Acute Intracranial Atherosclerotic Large Vessel Occlusion (ANGEL-REBOOT 2)

NCT07618052 | Not Yet Recruiting DMC

• 1 other identifier: HX-A-2026023
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

A multicenter, randomized, open-label, blinded-endpoint trial with a concurrent prospective observational cohort to compare bailout intracranial angioplasty or stenting versus standard therapy on functional outcome, stroke recurrence, and mortality in patients with acute intracranial atherosclerotic stenosis-related large vessel occlusion after thrombectomy.

Conditions

Intracranial Atherosclerotic Stenosis-Related Large Vessel Occlusion; Acute Ischemic Stroke; Bailout Angioplasty or Stenting

Keywords

Acute Intracranial Atherosclerotic Stenosis-Related Large Vessel Occlusion; Endovascular Thrombectomy; Bailout Angioplasty or Stenting

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the mRS score at 90 (±7) days after randomization (or after enrollment), analyzed as an ordinal variable

  The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death.

  90±7 days after randomization (or after enrollment)

Secondary Outcomes (10)

• The proportion of mRS 0-1, 0-2 and 0-3 at 90 (±7) days

  90±7 days after randomization (or after enrollment)

• The rate of stroke recurrence in the target vessel territory within 90 (±7) days

  90±7 days after randomization (or after enrollment)

• NIHSS score at 24 (±6/+12) hours

  24 (-6/+12) hours after randomization (or after enrollment)

• European Five Dimensional Health Scale Level 5 (EQ-5D-5L) score at 90±7 days

  90±7 days after randomization (or after enrollment)

• Patency of the target vessel at 24 (±6/+12) hours after the procedure, as confirmed by CTA, MRA, DSA, or TCD

  24 (-6/+12) hours after randomization (or after enrollment)

Other Outcomes (7)

• The rate of any Symptomatic intracranial hemorrhage (sICH) defined as the Heidelberg classification within 24 hours

  24 (-6/+12) hours after randomization (or after enrollment)

• The rate of all-cause mortality within 90 days

  90±7 days after randomization (or after enrollment)

• The rate of any intracranial hemorrhage identified by CT or MRI imaging within 24 hours after randomization

  24 (-6/+12) hours after randomization

Study Arms (2)

Intervention group

EXPERIMENTAL

Bailout Angioplasty or Stenting (BAOS) Group

Procedure: Bailout Intracranial Angioplasty or Stenting

Control group

OTHER

Standard Ttherapy Group

Procedure: Standard Thrombectomy

Interventions

Bailout Intracranial Angioplasty or Stenting PROCEDURE

Balloon angioplasty and/or stent placement for residual severe stenosis (≥70%) after successful thrombectomy; combined with medical management (intravenous tirofiban, followed by dual antiplatelet therapy with aspirin 100 mg/day and clopidogrel 75 mg/day for 90 days, then single antiplatelet therapy thereafter; and cerebrovascular risk factor management).

Intervention group

Standard Thrombectomy PROCEDURE

Endovascular thrombectomy performed according to guideline recommendations, without additional endovascular intervention; combined with medical management (intravenous tirofiban as needed, dual antiplatelet therapy with aspirin 100 mg/day and clopidogrel 75 mg/day for 90 days, then single antiplatelet therapy thereafter; and cerebrovascular risk factor management).

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18 years.
• Time interval from symptom onset to puncture ≤24 hours.
• National Institute of Health Stroke Scale (NIHSS) Score ≥6 before randomisation.
• Pre-stroke modified Rankin Scale (mRS) of 0-2.
• Each patient or their legal representative must provide written informed consent before enrolment.
• For patients with anterior circulation stroke, a CT or DWI-based Alberta Stroke Program Early CT Score (ASPECTS) of ≥6 is required.
• For patients with posterior circulation stroke, CT or DWI-based posterior circulation ASPECTS (pc-ASPECTS) of ≥6 and Pons-Midbrain Index (PMI) of \<3 are required.
• Acute ischemic stroke (AIS) resulting from large vessel occlusion (LVO) involving the intracranial internal carotid artery, the M1 segment of the middle cerebral artery, the V4 segment of the vertebral artery, or the basilar artery, with high suspicion of intracranial atherosclerotic stenosis-related large-vessel occlusion (ICAS-LVO).
• Part 1 (RCT): Successful recanalization of the occluded artery (eTICI ≥ 2b) with residual stenosis ≥ 70% after 1-2 thrombectomy attempts.
• Occluded artery amenable to angioplasty (balloon dilation and/or stenting) by the judgement of the treating neurointerventionalist.

You may not qualify if:

• Any sign of intracranial hemorrhage (ICH, except microbleeds) on baseline brain imaging.
• CT or MR imaging evidence of intracranial tumor (except small meningiomas or cerebral aneurysms \< 3mm in diameter).
• Any indication of intracranial vessel perforation during thrombectomy..
• Presence of tandem lesion in the extracranial segment of the internal carotid artery or vertebral artery, or intracranial arterial stenosis with distal vessel occlusion..
• Stenosis caused by non-atherosclerotic intracranial arteriopathies (e.g., autoimmune vasculitis, vasospasm, cerebral artery dissection).
• Evidence of cardioembolism (e.g., atrial fibrillation, prosthetic heart valve, infective endocarditis, mitral stenosis, atrial myxoma, intracardiac thrombus/vegetation, left ventricular aneurysm, etc.).
• Contraindication for antiplatelet treatment.
• Excessive vascular tortuosity or anatomical variants that may preclude successful delivery or positioning of interventional devices.
• History of contraindication to the use of contrast medium.
• Refractory hypertension (defined as systolic blood pressure\>185 mmHg or diastolic blood pressure\>110 mmHg) that cannot be controlled by drug treatment.
• Known hereditary or acquired bleeding tendency, lack of coagulation factors, or oral anticoagulants with INR\>1.5.
• Blood glucose\<2.8 or\>22.2 mmol/L; Platelet count\<100\*109/L, serum creatinine\>2.0 g/L (177 μ mol/L), or glomerular filtration rate\<30 ml/(min\*1.73 m2).
• Concurrent participation in another drug or device trial, or expected participation within the following 3 months.
• Patients whose life expectancy is less than 1 year (such as patients with malignant tumor, advanced cardiopulmonary disease, etc.).
• Known pregnancy or lactation, or positive pregnancy test before randomization (or before enrollment).

Sponsors & Collaborators

• Feng Gao: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Stents

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Feng Gao, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Gao, MD

CONTACT

13581936066; gaofengletter@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice-Director of Interventional Neuroradiology, Department of Neurology

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 1, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)