Actively Recruiting
A Prospective, Multi-center, Randomized Controlled Trial to Evaluate the Safety and Feasibility of Intracranial Drug-coated Balloon Catheter in the Treatment of Intracranial In-stent Restenosis
Led by Acotec Scientific Co., Ltd · Updated on 2024-08-01
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
A
Acotec Scientific Co., Ltd
Lead Sponsor
B
Beijing Tiantan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and practicality of using a drug-coated balloon catheter to treat intracranial in-stent restenosis, a condition where arteries inside the brain narrow again after stent placement. This prospective, multi-center, randomized controlled trial compares a paclitaxel-coated balloon to a traditional uncoated PTA balloon to find out which approach is better for this condition. Participants receive treatment using either the drug-coated balloon or the PTA balloon, targeting intracranial arteries with in-stent restenosis. The study involves random assignment to one of these two groups, and the treatment is applied during a procedure to open narrowed brain arteries. The trial monitors participants for stroke or death events within 30 days and follows them up to 12 months to assess device success and various stroke-related outcomes. Throughout the study, participants undergo evaluations including imaging tests, neurological assessments, and functional scores like the National Institutes of Health Stroke Scale and Modified Rankin Score at 12 months. Researchers track safety events such as hemorrhages and ischemic strokes, and monitor vessel health. The total participation duration covers the initial procedure and follow-up assessments over a year, aiming to gather detailed information on treatment effects and safety.
CONDITIONS
Brief Title
ACOART Intracranial ISR Pilot:Intracranial DCB in the Treatment of Intracranial In-stent Restenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 to 80 years of age
- Confirmed by DSA: in-stent restenosis in intracranial internal carotid, middle cerebral, basilar, or vertebral arteries with >50% stenosis or >20% luminal loss
- Presence of ischemic stroke or transient ischemic attacks related to ISR despite medical treatment
- Asymptomatic ISR with severe hypoperfusion confirmed by CT perfusion or collateral flow grading
- Target vessel diameter between 2.0 and 4.5 mm
- Only one intracranial ISR lesion per participant
- Baseline Modified Rankin Score of 2 or less
- Voluntary participation with signed informed consent
You will not qualify if you...
- Stroke within 2 weeks before procedure
- History of brain or intracranial hemorrhage within past 30 days
- Thrombolysis received within 24 hours before procedure
- Neurological worsening within 24 hours before procedure (NIHSS score increased by 4 or more)
- Thrombus in target vessels
- Other primary intracranial lesions needing treatment besides ISR
- Major surgery planned or performed within past 30 or 90 days
- Simultaneous intervention needed for renal, iliac, or cardiac arteries
- Intracranial tumors, aneurysms, or arteriovenous malformations
- Cardiac stroke or potential cardiogenic embolism causes
- Myocardial infarction within 6 weeks before procedure
- Unable to tolerate general anesthesia due to organ insufficiency
- Severe liver or kidney dysfunction
- Low hemoglobin, low platelets, high INR, or bleeding risks
- Unable to receive or tolerate dual antiplatelet therapy
- Severe allergies to heparin, paclitaxel, contrast agents, or related drugs
- Current alcohol or drug abuse, uncontrolled severe hypertension
- Life expectancy less than 1 year
- Pregnant or lactating women
- Cognitive, emotional, or mental illness preventing follow-up
- Participation in other drug/device trials without completed follow-up
- Other investigator-determined unsuitable conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive implantation of either a drug (paclitaxel) coated balloon catheter or a traditional PTA balloon to treat intracranial in-stent restenosis.
1 procedure visit (in-person)
Duration - 12 months
Participants are monitored for safety and treatment outcomes including stroke events and neurological assessments.
Approximately 5 follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, China
Actively Recruiting
Research Team
N
Ning Ma, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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