Balloon angioplasty vs stenting after residual intracranial narrowing in acute ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter study compares rescue balloon angioplasty to rescue stenting in adults with intracranial atherosclerotic stroke who still have at least 50% stenosis after initial endovascular treatment. It is a randomized, open-label trial with blinded outcome assessment, enrolling up to 486 participants in a 1:1 ratio. In the angioplasty arm, additional stenting is allowed if results are not satisfactory; in the stenting arm, balloon angioplasty may accompany stent placement when clinically indicated. All participants receive standard medical management per the protocol, and the primary outcome is functional independence at follow-up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18 years or older.
2. Pre-stroke modified Rankin Scale (mRS) score of 0-1.
3. Symptoms of acute ischemic stroke presenting within 24 hours of the last known well time.
4. Baseline National Institutes of Health Stroke Scale (NIHSS) score of at least 6.
5. Baseline Alberta Stroke Program Early CT Score (ASPECTS) of at least 6 for anterior-circulation stroke, or posterior-circulation ASPECTS (pc-ASPECTS) of at least 6 for posterior-circulation stroke.
6. Occlusion of the intracranial internal carotid artery, M1 segment of the middle cerebral artery, V4 segment of the vertebral artery, or basilar artery.
7. The clinical care team plans to perform endovascular treatment.
8. The participant or the participant's legally authorized representative is able to provide written informed consent.
9. Baseline CT perfusion or MR perfusion imaging demonstrating an ischemic core volume of less than 70 mL, a mismatch ratio of at least 1.2, and a mismatch volume of at least 15 mL.
10. Intracranial atherosclerosis is considered the underlying etiology, with residual stenosis of at least 50% after endovascular treatment, and rescue balloon angioplasty or stenting is planned

Exclusion Criteria:

1. Any intracranial hemorrhage identified on imaging before randomization; or major intracranial hemorrhage, defined as parenchymal hematoma type 1 or type 2, identified on intraprocedural flat-panel CT. Parenchymal hematoma type 1 is defined as blood clots involving less than 30% of the infarcted area, with or without a slight space-occupying effect; parenchymal hematoma type 2 is defined as blood clots involving more than 30% of the infarcted area with a substantial space-occupying effect.
2. Gastrointestinal or genitourinary bleeding within 30 days before stroke onset, or major surgery within 14 days before stroke onset.
3. Bleeding diathesis, including platelet count below 100 × 10⁹/L, activated partial thromboplastin time greater than 50 seconds, or international normalized ratio greater than 2.0; treatment with a direct oral anticoagulant within the preceding 48 hours; or a history of heparin-induced thrombocytopenia.
4. Pregnancy or breastfeeding at admission.
5. Contraindication to iodinated contrast agents, nickel, titanium, or their alloys.
6. Life expectancy of less than 6 months.
7. Pre-existing neurological or psychiatric disease that may confound neurological or functional outcome assessment.
8. Severe renal impairment, defined as glomerular filtration rate below 30 mL/min or serum creatinine above 220 μmol/L (2.5 mg/dL).
9. Arterial tortuosity or another arterial condition that would prevent the study device from reaching the target vessel.
10. Unlikely to complete the 90-day follow-up.
11. Any definite cardioembolic source, including chronic or paroxysmal atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical heart valve, endocarditis, history of atrial or ventricular thrombus, myocardial infarction within the preceding 3 months, dilated cardiomyopathy, spontaneous echo contrast in the left atrium, or left ventricular ejection fraction below 30%.
12. Use of any glycoprotein IIb/IIIa inhibitor other than tirofiban.

Where it's running

• Beijing Anzhen Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Xiaochuan Huo, Doctor
• Email: hxc810909@163.com
• Phone: +86 13716292262

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.