NCT06014723Recruiting
Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA
Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA: a Prospective, Multi-center, Register Study
Source: ClinicalTrials.gov · Last updated 3 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The objective of this study was to evaluate the safety and efficacy of early submaximal balloon angioplasty combined with medical therapy vs medical therapy alone for minor stroke/transient ischemic attack with intracranial atherosclerosis etiology.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 416 (estimated)
- First submitted
- 21 Aug 2023
- Start date
- 23 Aug 2023
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Shouchun Wang, MD, PhD
- Diseases
- Stroke
- NCT number
- NCT06014723
What you commit to
- Study type: Observational
- Planned participants: 416
- From 23 Aug 2023 to the primary completion date, 1 Sept 2026
- 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
- previous endovascular treatment of the ipsilateral vessel;
- history of major surgery within 30 days prior to enrollment or surgery plan within 90 days after enrollment;
Other illness
- allergy to contrast media;
- non-atherosclerotic disease-related stenosis, such as arterial dissection, Moya-Moya disease, and arteritis;
- any form of ipsilateral intracranial hemorrhage within 3 months and contralateral intracranial hemorrhage within 2 weeks;
- presence of atrial fibrillation, severe heart dysfunction, liver or kidney dysfunction; patients with tumors and serious diseases whose expected survival time is ≤ 1 year;
- uncontrollable hypertension: systolic blood pressure \>185 mmHg and/or diastolic blood pressure \>110 mmHg;
- other conditions that the researchers think make the patient unsuitable for the study.
Lab values
- hemoglobin ≤ 100g/L, platelet count ≤ 100×10\^9/L, INR\> 1.5 (irreversible), coagulopathy or irremediable bleeding factors;
- poor glycemic control (random blood glucose \> 22.2 mmol/L);
Other
- penetrating branch lesion ipsilateral to the target lesion (infarction caused by penetrating branch occlusion is defined as stenosis of the MCA or BA, but only with simple basal ganglia or brainstem/thalamic infarction);
- presence of severe stenosis of the extracranial segment on the side of the target lesion;
- presence of intracranial aneurysms, tumors, and vascular malformations;
- pregnancy or lactation;
Who the study is looking for
- age range of 30-80 years;
- symptomatic ICAS (C4-C7 segments of ICA, M1 segment of the MCA, V4 segment of the VA, and BA) with 70%-99% stenosis confirmed by DSA;
- minor stroke (NIHSS score ≤5) within 1 week of onset or from symptom exacerbation (NIHSS score increased by ≥2 points) or intermediate- to high-risk TIA, defined as ABCD2 score ≥4 within 1 week of the last symptom episode;
- diameter of the culprit artery ranging from 2.0 to 4.5mm, and the length of the stenosis≤14mm;
- mRS ≤ 2 before endovascular treatment;
- no large ischemic region found on CT or MRI (ASPECTS≥ 6 or pc-ASPECTS ≥8);
- written informed consent obtained from the patient or legally responsible person.
Age in the registry: 30 years to 80 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.