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

NCT07026344 — Not applicable, Active not recruiting, 312 participants, Beijing Anzhen Hospital

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

RegistryNCT07026344, acronym ANGEL-RESCUE
StatusActive not recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment312 (Estimated)
SponsorBeijing Anzhen Hospital (Other)
ConditionsAcute Ischemic Stroke
InterventionsStent placement, Continued Thrombectomy, balloon angioplasty (Procedure)
Datesstart 2025-07-12, primary completion 2027-03-01 (estimated), completion 2027-04-01 (estimated), first posted 2025-06-18, last updated 2025-08-13
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Acute Ischemic Stroke All trials of Stent placement All trials of Continued Thrombectomy

-Summary

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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+Arms and interventions

ArmTypeInterventionsDescription
Stenting or Angioplasty GroupExperimentalProcedure: Stent placement; Procedure: balloon angioplastyIf recanalization is not achieved after 3-5 attempts of thrombectomy, direct stent placement or balloon angioplasty is performed.
Continued Thrombectomy GroupActive comparatorProcedure: Continued ThrombectomyIf recanalization is not achieved after 3-5 attempts of thrombectomy, at least one additional thrombectomy attempt is performed
  • 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.

+Outcome measures

Primary outcomes

  • Proportion of patients with mRS 0-2 [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

  • Change in NIHSS score from baseline [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
  • Vascular recanalization rate assessed by CT/MR angiography [at 36±12 hours post-randomization]: Vascular recanalization rate assessed by CT/MR angiography
  • Change in infarct volume [at 7±3 days post-randomization or discharge (whichever comes first)]: Change in infarct volume
  • Distribution of mRS scores [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.
  • Proportion of patients achieving mRS 0-1 [90±7 days]: Proportion of patients achieving mRS 0-1
  • Incidence of rescue therapy [90±7 days]: Incidence of rescue therapy
  • EQ-5D-5L utility score [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.
  • Probability of symptomatic intracranial hemorrhage [48 hours]: Probability of symptomatic intracranial hemorrhage
  • All-cause mortality [90±7 days post-randomization]: All-cause mortality
  • Probability of any intracranial hemorrhage (per Heidelberg criteria) [48 hours post-randomization]: Probability of any intracranial hemorrhage (per Heidelberg criteria)

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Age ≥18 years
2. Pre-stroke mRS 0-1
3. Symptoms of AIS present within 24 hours of last known well time
4. Baseline NIHSS score ≥6
5. Anterior circulation: ASPECTS ≥6; Posterior circulation: pc-ASPECTS ≥6
6. Occlusion of intracranial ICA, M1 segment of MCA, V4 segment of vertebral artery, or basilar artery
7. Clinical care team intends to perform endovascular therapy (EVT)
8. 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
9. Subject or legally authorized representative can provide informed consent

Exclusion Criteria:

1. Intracranial hemorrhage confirmed by imaging prior to randomization; or intraprocedural flat-panel CT evidence of major hemorrhage
2. Gastrointestinal or genitourinary bleeding within 30 days post-stroke onset; or major surgery within 14 days
3. 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)
4. Pregnancy or lactation at admission
5. Contraindications to:Radiographic contrast agents; Nickel, titanium, or their alloys (device-related)
6. Life expectancy <6 months
7. Pre-existing neurological/psychiatric conditions that may confound neurological assessment
8. Severe renal insufficiency:GFR <30 mL/min or Serum creatinine >220 μmol/L (2.5 mg/dL)
9. Arterial tortuosity or other vascular anomalies preventing device delivery to target vessel
10. Unlikely to complete 90-day follow-up

+Locations (1)

FacilityCityCountryStatus
Beijing Anzhen Hospital Affiliated to Capital Medical UniversityBeijing, Beijing MunicipalityChina