Randomized Study of Bailout Intracranial Angioplasty Following Thrombectomy for Acute Large Vessel Occlusion

NCT05122286 | Completed DMC

• 1 other identifier: HA-X-026(2020)
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Acute Ischemic Stroke

Keywords

Endovascular treatment; Large vessel occlusion; Angioplasty; Thrombectomy

Outcome Measures

Primary Outcomes (1)

• 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

  90±14 days after randomization

Secondary Outcomes (13)

• Rate of good functional outcome (mRS 0-2) at 90 (±14) days after randomization

  90±14 days after randomization

• Rate of independent ambulation (mRS 0-3) at 90 (±14) days after randomization

  90±14 days after randomization

• Functional health status and quality of life (EQ-5D-5L) at 90 (±14) days after randomization

  90±14 days after randomization

• Technical success defined as successful recanalization (eTICI 2b-3) of the occluded vessel at the end of the procedure

  The end of the procedure

• Infarct volume on FLAIR/T2WI or CT after 18-36 hours of randomization

  18-36 hours after randomization

Study Arms (2)

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.

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.

Procedure: Standard therapy

Interventions

Bailout angioplasty PROCEDURE

Use balloons or stents for bailout angioplasty

Bailout angioplasty

Standard therapy PROCEDURE

Stop the endovascular recanalization procedure or to perform further recanalization attempts using stent-retrievers and/or aspiration catheters

Standard therapy

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
• Pre-stroke mRS 0\~2
• Acute ischemic stroke (NIHSS ≥ 6)
• Time-last-known-well to puncture ≤ 24 hours
• Informed consent
• Anterior circulation stroke: CT or DWI ASPECTS ≥ 6; Posterior circulation stroke: CT or DWI pc-ASPECTS ≥ 6 and Pons-Midbrain Index (PMI)\<3
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location

Related Publications (4)

• 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.

  PMID: 41122847 DERIVED

• Li 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.

  PMID: 40485466 DERIVED

• Gao 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.

  PMID: 38914085 DERIVED

• Gao 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.

  PMID: 37474136 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Zhongrong Miao, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

• Feng Gao, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

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: PRINCIPAL INVESTIGATOR
• PI Title: Director of Interventional Neuroradiology, Department of Neurology

Study Record Dates

• First Submitted: September 25, 2021
• First Posted: November 16, 2021
• Study Start: December 19, 2021
• Primary Completion: June 2, 2023
• Study Completion: August 20, 2023
• Last Updated: August 22, 2023

Record last verified: 2023-08

Locations

CN (1)