Acute Ischemic StrokeANGEL-RESCUENCT07026344
Efficacy of Rescue Stenting/Angioplasty After Failed Thrombectomy for Acute Large Intracranial Vascular Occlusion
A study testing Stent placement, Continued Thrombectomy and balloon angioplasty in people with Acute Ischemic Stroke, run by Beijing Anzhen Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Stent placement, Continued Thrombectomy and balloon angioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteChina
- Study dates
- 12 Jul 2025to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Anzhen Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 101118
About this study
Official 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
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.
Read more
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
- Being tested
- Stent placement, Continued Thrombectomy, balloon angioplasty
- Keywords
- Acute Ischemic Stroke, Thrombectomy, Large Intracranial Vascular Occlusion, Rescue Stenting, Randomized Controlled Trial
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent placementProcedure or surgery
For patients who fail thrombectomy, perform stent placement.
Continued ThrombectomyProcedure or surgery
For patients with failed thrombectomy, perform at least one additional thrombectomy attempt
balloon angioplastyProcedure or surgery
For patients who fail thrombectomy, perform balloon angioplasty.
| Study group | Role | What they receive |
|---|---|---|
| Stenting or Angioplasty Group | Experimental | If recanalization is not achieved after 3-5 attempts of thrombectomy, direct stent placement or balloon angioplasty is performed. Receives: 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 Receives: Procedure: Continued Thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90±7 days
Secondary outcomes (10)
Change in NIHSS score from baseline
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
Measured: 36±12 hours post-randomization
Vascular recanalization rate assessed by CT/MR angiography
Vascular recanalization rate assessed by CT/MR angiography
Measured: at 36±12 hours post-randomization
Change in infarct volume
Change in infarct volume
Measured: at 7±3 days post-randomization or discharge (whichever comes first)
Distribution of mRS scores
Modified Rankin Scale（0-6）, A lower MRS score indicates better functional status for the patient.
Measured: 7±3 days/discharge and 90±7 days post-randomization
Proportion of patients achieving mRS 0-1
Proportion of patients achieving mRS 0-1
Measured: 90±7 days
Incidence of rescue therapy
Incidence of rescue therapy
Measured: 90±7 days
EQ-5D-5L utility score
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.
Measured: 90±7 days
Probability of symptomatic intracranial hemorrhage
Probability of symptomatic intracranial hemorrhage
Measured: 48 hours
All-cause mortality
All-cause mortality
Measured: 90±7 days post-randomization
Probability of any intracranial hemorrhage (per Heidelberg criteria)
Probability of any intracranial hemorrhage (per Heidelberg criteria)
Measured: 48 hours post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start12 Jul 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026344
- Sponsor's protocol ID
- ANGEL-RESCUE
- Acronym
- ANGEL-RESCUE
- Status last verified
- Aug 2025
- First submitted
- 3 Jun 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07026344
- Acronym / sponsor ID
- ANGEL-RESCUE / ANGEL-RESCUE
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Thrombectomy, Large Intracranial Vascular Occlusion, Rescue Stenting, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 12 Jul 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stenting or Angioplasty Group | Experimental | Procedure: 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 Group | Active comparator | Procedure: Continued ThrombectomyIf recanalization is not achieved after 3-5 attempts of thrombectomy, at least one additional thrombectomy attempt is performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stent placementFor patients who fail thrombectomy, perform stent placement. | Procedure or surgery | Stenting or Angioplasty Group |
| Continued ThrombectomyFor patients with failed thrombectomy, perform at least one additional thrombectomy attempt | Procedure or surgery | Continued Thrombectomy Group |
| balloon angioplastyFor patients who fail thrombectomy, perform balloon angioplasty. | Procedure or surgery | Stenting or Angioplasty Group |
Primary outcome
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.
10 secondary outcomes
Change in NIHSS score from baseline
Time frame: 36±12 hours post-randomization
Vascular recanalization rate assessed by CT/MR angiography
Time frame: at 36±12 hours post-randomization
Change in infarct volume
Time frame: at 7±3 days post-randomization or discharge (whichever comes first)
Distribution of mRS scores
Time frame: 7±3 days/discharge and 90±7 days post-randomization
Proportion of patients achieving mRS 0-1
Time frame: 90±7 days
Incidence of rescue therapy
Time frame: 90±7 days
EQ-5D-5L utility score
Time frame: 90±7 days
Probability of symptomatic intracranial hemorrhage
Time frame: 48 hours
All-cause mortality
Time frame: 90±7 days post-randomization
Probability of any intracranial hemorrhage (per Heidelberg criteria)
Time frame: 48 hours post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stent placement, Continued Thrombectomy and balloon angioplasty in people with Acute Ischemic Stroke, run by Beijing Anzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with mRS 0-2 (time frame: 90±7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.