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NCT Number: NCT07026344

Efficacy of Rescue Stenting/Angioplasty After Failed Thrombectomy for Acute Large Intracranial Vascular Occlusion

The primary objective of this study is to evaluate whether rescue stenting therapy can improve neurological functional outcomes after failed endovascular treatment for acute ischemic stroke caused by large vessel occlusion. The study population is divided into two groups:

Stent Placement Group: If recanalization is not achieved after 3-5 attempts of thrombectomy, direct stent placement or balloon angioplasty is performed.

Continued Thrombectomy Group: If recanalization is not achieved after 3-5 attempts of thrombectomy, at least one additional thrombectomy attempt is performed.

The primary efficacy endpoint is the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-2 at 90±7 days.

The safety endpoint is the incidence of symptomatic intracranial hemorrhage within 48 hours after randomization.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Anzhen Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 101118, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Pre-stroke mRS 0-1
  • Symptoms of AIS present within 24 hours of last known well time
  • Baseline NIHSS score ≥6
  • Anterior circulation: ASPECTS ≥6; Posterior circulation: pc-ASPECTS ≥6
  • Occlusion of intracranial ICA, M1 segment of MCA, V4 segment of vertebral artery, or basilar artery
  • Clinical care team intends to perform endovascular therapy (EVT)
  • Failure to achieve recanalization (eTICI 0-1) after 3 thrombectomy attempts, including: At least one contact aspiration attempt; At least one stent retriever attempt or combined approach
  • Subject or legally authorized representative can provide informed consent

Exclusion criteria

  • Intracranial hemorrhage confirmed by imaging prior to randomization; or intraprocedural flat-panel CT evidence of major hemorrhage
  • Gastrointestinal or genitourinary bleeding within 30 days post-stroke onset; or major surgery within 14 days
  • Bleeding diathesis, including:Laboratory evidence of coagulopathy (PLT <100×10⁹/L, aPTT >50 sec, or INR >2.0); Direct oral anticoagulant (DOAC) use within 48 hours prior; History of heparin-induced thrombocytopenia (HIT)
  • Pregnancy or lactation at admission
  • Contraindications to:Radiographic contrast agents; Nickel, titanium, or their alloys (device-related)
  • Life expectancy <6 months
  • Pre-existing neurological/psychiatric conditions that may confound neurological assessment
  • Severe renal insufficiency:GFR <30 mL/min or Serum creatinine >220 μmol/L (2.5 mg/dL)
  • Arterial tortuosity or other vascular anomalies preventing device delivery to target vessel
  • Unlikely to complete 90-day follow-up

Treatment and study plan

Stent placement

Procedure

For patients who fail thrombectomy, perform stent placement.

Continued Thrombectomy

Procedure

For patients with failed thrombectomy, perform at least one additional thrombectomy attempt

Balloon angioplasty

Procedure

For patients who fail thrombectomy, perform balloon angioplasty.

Primary outcomes

  1. Proportion of patients with mRS 0-2

    Time frame: 90±7 days

    Proportion of patients with Modified Rankin Scale (mRS) 0-2, Modified Rankin Scale（0-6）, A lower MRS score indicates better functional status for the patient.

Secondary outcomes

  1. Change in NIHSS score from baseline

    Time frame: 36±12 hours post-randomization

    Change in National Institute of Health stroke scale score from baseline.The NIH Stroke Scale (NIHSS) score ranges from 0 to 42 points, with lower scores indicating better neurological function

  2. Vascular recanalization rate assessed by CT/MR angiography

    Time frame: at 36±12 hours post-randomization

    Vascular recanalization rate assessed by CT/MR angiography

  3. Change in infarct volume

    Time frame: at 7±3 days post-randomization or discharge (whichever comes first)

    Change in infarct volume

  4. Distribution of mRS scores

    Time frame: 7±3 days/discharge and 90±7 days post-randomization

    Modified Rankin Scale（0-6）, A lower MRS score indicates better functional status for the patient.

  5. Proportion of patients achieving mRS 0-1

    Time frame: 90±7 days

    Proportion of patients achieving mRS 0-1

  6. Incidence of rescue therapy

    Time frame: 90±7 days

    Incidence of rescue therapy

  7. EQ-5D-5L utility score

    Time frame: 90±7 days

    The EuroQol 5-Dimension 5-Level Utility Score (EQ-5D-5L utility score) ranges from -0.594 to 1.000 (Chinese value set), assessing health-related quality of life, with higher scores indicating better health status.

  8. Probability of symptomatic intracranial hemorrhage

    Time frame: 48 hours

    Probability of symptomatic intracranial hemorrhage

  9. All-cause mortality

    Time frame: 90±7 days post-randomization

    All-cause mortality

  10. Probability of any intracranial hemorrhage (per Heidelberg criteria)

    Time frame: 48 hours post-randomization

    Probability of any intracranial hemorrhage (per Heidelberg criteria)

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Official study title

Efficacy of Rescue Stenting/Angioplasty After Failed Thrombectomy for Acute Large Intracranial Vascular Occlusion: A Multicenter, Prospective, Open-label, Endpoint-blinded, Randomized Controlled Trial

Acronym: ANGEL-RESCUE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2025
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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