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

NCT07026344 | Active Not Recruiting DMC

• 1 other identifier: ANGEL-RESCUE
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke; Thrombectomy; Large Intracranial Vascular Occlusion; Rescue Stenting; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with mRS 0-2

  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.

  90±7 days

Secondary Outcomes (10)

• Change in NIHSS score from baseline

  36±12 hours post-randomization

• Vascular recanalization rate assessed by CT/MR angiography

  at 36±12 hours post-randomization

• Change in infarct volume

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

• Distribution of mRS scores

  7±3 days/discharge and 90±7 days post-randomization

• Proportion of patients achieving mRS 0-1

  90±7 days

Study Arms (2)

Stenting or Angioplasty Group

EXPERIMENTAL

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

Procedure: Stent placement; Procedure: balloon angioplasty

Continued Thrombectomy Group

ACTIVE COMPARATOR

If recanalization is not achieved after 3-5 attempts of thrombectomy, at least one additional thrombectomy attempt is performed

Procedure: Continued Thrombectomy

Interventions

Stent placement PROCEDURE

For patients who fail thrombectomy, perform stent placement.

Stenting or Angioplasty Group

Continued Thrombectomy PROCEDURE

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

Continued Thrombectomy Group

balloon angioplasty PROCEDURE

For patients who fail thrombectomy, perform balloon angioplasty.

Stenting or Angioplasty 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 101118, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Angioplasty, Balloon

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

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

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 18, 2025
• Study Start: July 12, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)