The New Clinical Registration Trial of Interventional Treatment for Patients with Symptomatic Intracranial Artery Stenosis

Launched by XUANWU HOSPITAL, BEIJING · Dec 13, 2024

Keywords

ClinConnect Summary

The clinical trial titled "The New Clinical Registration Trial of Interventional Treatment for Patients with Symptomatic Intracranial Artery Stenosis" is investigating the effects and safety of a specific treatment approach for patients with a condition called symptomatic intracranial atherosclerotic stenosis (sICAS), which can lead to strokes. This study aims to explore whether a combination of a procedure called endovascular treatment (which helps open narrowed blood vessels in the brain) along with standard medical therapy is more effective than just medical treatment alone. The trial will involve over 1,000 participants, and it will collect detailed information about their health and recovery over several years, starting in December 2024.

To be eligible for the trial, participants must be between 18 and 80 years old, have experienced a stroke or a mini-stroke in the last year due to significant narrowing of major brain arteries, and be willing to attend follow-up appointments. However, certain conditions, such as other serious vascular issues or pregnancy, might exclude someone from participating. Participants will be closely monitored for any complications and overall health improvements during the study period, which will last until December 2028. This research is important because it could help improve treatment options for patients with this serious condition, potentially leading to better outcomes and fewer strokes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • (1)18-80 years old; (2)Received endovascular therapy during hospitalization; (3) Intracranial arterial stenosis related to the following non-atherosclerotic factors will be not be considered: arterial dissection, moya-moya disease; vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with cerebrospinal fluid pleocytosis; radiation-induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; postpartum angiopathy; suspected vasospastic process, and suspected recanalized embolus; (4) Symptomatic intracranial stenosis: presented with transient ischemic stroke (TIA) or stroke within the past 12 months attributed to 70%-99% stenosis of a major intracranial artery (ICA, MCA \[M1\], vertebral artery, or basilar artery \[BA\]); (5) Degree of stenosis: 70%-99%; stenosis degree must be consistent with the criteria of endovascular treatment ; (6) No massive cerebral infarction (\>1/2 MCA territory), intracranial hemorrhage, epidural or sub-dural hemorrhage, and intracranial brain tumor on CT or MRI scan; (7) Patient is willing and able to return for all follow-up visits required by the protocol; (8) Patient understands the purpose and requirements of the study, can make him/herself understood, and has signed informed consent.
• Exclusion Criteria:
• • 1. Patients had cerebrovascular diseases, e.g., intracranial aneurysm or vascular malformation, and intracranial tumors;
• • 2. History of life-threatening allergy to contrast medium. If not life threatening and can be effectively pre-treated, patient can be enrolled at physicians' discretion;
• • 3. Active bleeding diathesis or coagulopathy; active peptic ulcer disease, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets count \<125,000, hematocrit \<30, Hgb \<10g/dL, uncorrected INR \>1.5, bleeding time \>1 minute beyond upper limit normal, or heparin-associated thrombocytopenia that increases the risk of bleeding, uncontrolled severe hypertension (systolic BP\>180mmHg or diastolic BP\>115mmHg), severe liver impairment (AST or ALT \>3 times normal, cirrhosis), creatinine \>265.2 mmol/L (unless on dialysis).
• • 4. Major surgery (including open femoral, aortic, or carotid surgery) within previous 30 days or planned in the next 90 days after enrollment;
• • 5. Severe dementia or psychiatric problems that prevent the patients from following an outpatient program reliably;
• • 6. Pregnancy or of childbearing potential and unwilling to use contraception for the duration of this study.