Acute Ischemic Stroke study: Stent
Official title Effect of Balloon Angioplasty vs Stenting Following Residual Stenosis After Endovascular Treatment of Intracranial Atherosclerotic Acute Ischemic Stroke
ClinicalTrials.gov ID: NCT07026331
What this study is testing
- What it's testing
- The ANGEL-ICAS trial is a blinded-endpoint study designed to find out whether rescue balloon angioplasty is noninferior to rescue stenting in patients with intracranial atherosclerosis-related acute ischemic stroke who have residual intracranial arterial stenosis of at least 50% after endovascular treatment and require additional rescue therapy.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 years or older.
- Pre-stroke modified Rankin Scale (mRS) score of 0-1.
- Symptoms of acute ischemic stroke presenting within 24 hours of the last known well time.
- Baseline National Institutes of Health Stroke Scale (NIHSS) score of at least 6.
- Baseline Alberta Stroke Program Early CT Score (ASPECTS) of at least 6 for anterior-circulation stroke, or posterior-circulation ASPECTS (pc-ASPECTS)...
You likely can't join if
- Any intracranial hemorrhage identified on imaging before randomization
- Gastrointestinal or genitourinary bleeding within 30 days before stroke onset, or major surgery within 14 days before stroke onset.
- Bleeding diathesis, including platelet count below 100 × 10⁹/L, activated partial thromboplastin time greater than 50 seconds, or international...
- Pregnancy or breastfeeding at admission.
- Contraindication to iodinated contrast agents, nickel, titanium, or their alloys.
- Life expectancy of less than 6 months.
See the full eligibility criteria
- Age 18 years or older.
- Pre-stroke modified Rankin Scale (mRS) score of 0-1.
- Symptoms of acute ischemic stroke presenting within 24 hours of the last known well time.
- Baseline National Institutes of Health Stroke Scale (NIHSS) score of at least 6.
- 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.
- Occlusion of the intracranial internal carotid artery, M1 segment of the middle cerebral artery, V4 segment of the vertebral artery, or basilar artery.
- The clinical care team plans to perform endovascular treatment.
- The participant or the participant's legally authorized representative is able to provide written informed consent.
- 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.
- 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
- 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.
- Gastrointestinal or genitourinary bleeding within 30 days before stroke onset, or major surgery within 14 days before stroke onset.
- 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
- Pregnancy or breastfeeding at admission.
- Contraindication to iodinated contrast agents, nickel, titanium, or their alloys.
- Life expectancy of less than 6 months.
- Pre-existing neurological or psychiatric disease that may confound neurological or functional outcome assessment.
- Severe renal impairment, defined as glomerular filtration rate below 30 mL/min or serum creatinine above 220 μmol/L (2.5 mg/dL).
- Arterial tortuosity or another arterial condition that would prevent the study device from reaching the target vessel.
- Unlikely to complete the 90-day follow-up.
- 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...
- Use of any glycoprotein IIb/IIIa inhibitor other than tirofiban.
The study team makes the final eligibility decision.
Where it is enrolling
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Beijing, Beijing Municipality, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.