NCT07026344Active, not recruiting
Efficacy of Rescue Stenting/Angioplasty After Failed Thrombectomy for Acute Large Intracranial Vascular Occlusion
Efficacy of Rescue Stenting/Angioplasty After Failed Thrombectomy for Acute Large Intracranial Vascular Occlusion: A Multicenter, Prospective, Open-label, Endpoint-blinded, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 13 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 312 (estimated)
- First submitted
- 3 Jun 2025
- Start date
- 12 Jul 2025
- Primary completion date
- 1 Mar 2027
- Lead sponsor
- Beijing Anzhen Hospital
- Diseases
- Stroke
- NCT number
- NCT07026344
What you commit to
- Study type: Interventional
- Planned participants: 312
- From 12 Jul 2025 to the primary completion date, 1 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intracranial hemorrhage confirmed by imaging prior to randomization; or intraprocedural flat-panel CT evidence of major hemorrhage
Other illness
- Gastrointestinal or genitourinary bleeding within 30 days post-stroke onset; or major surgery within 14 days
- Pre-existing neurological/psychiatric conditions that may confound neurological assessment
Lab values
- 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)
- Severe renal insufficiency:GFR \<30 mL/min or Serum creatinine \>220 μmol/L (2.5 mg/dL)
Other
- Pregnancy or lactation at admission
- Contraindications to:Radiographic contrast agents; Nickel, titanium, or their alloys (device-related)
- Life expectancy \<6 months
- Arterial tortuosity or other vascular anomalies preventing device delivery to target vessel
- Unlikely to complete 90-day follow-up
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Anzhen Hospital Affiliated to Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.