Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT04627870

ACOART Intracranial ISR Pilot:Intracranial DCB 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

239 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

The purpose of the study is to evaluate the safety and feasibility of drug coated balloon in treatment of intracranial in-stent restenosis.

CONDITIONS

Official Title

ACOART Intracranial ISR Pilot:Intracranial DCB in the Treatment of Intracranial In-stent Restenosis

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years
  • In-stent restenosis confirmed by DSA at intracranial arteries (internal carotid, middle cerebral, basilar, vertebral) with >50% stenosis and >20% luminal loss
  • Ischemic stroke or transient ischemic attacks related to ISR despite medical treatment and risk control
  • 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 subject
  • Baseline modified Rankin Scale (mRS) score of 2 or less
  • Voluntary participation with signed informed consent
Not Eligible

You will not qualify if you...

  • Stroke within 2 weeks before procedure
  • Brain hemorrhage (parenchyma, subarachnoid, subdural, extradural) within past 30 days
  • Thrombolysis received within 24 hours before procedure
  • Neurological deterioration within 24 hours before procedure (NIHSS increase ≥4 points)
  • Presence of thrombus in target vessels
  • Other primary intracranial lesions requiring endovascular treatment
  • Major surgery within past 30 days or planned within 90 days
  • Renal artery, iliac artery, or coronary artery interventions needed simultaneously
  • Intracranial tumors, aneurysms, or arteriovenous malformations
  • Cardiac stroke or cardiogenic thromboembolism causes
  • Myocardial infarction within 6 weeks before procedure
  • Intolerance to general anesthesia due to heart, lung, or organ insufficiency
  • Severe hepatic or renal dysfunction
  • Hemoglobin < 100g/L, platelet count < 100,000/mm3, INR > 1.5, or bleeding risk
  • Inability to receive or tolerate dual antiplatelet therapy
  • Severe allergies or contraindications 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
  • Inability to complete follow-up due to cognitive, emotional, or mental disorders
  • Participation in other drug/device clinical trials without completed follow-up
  • Other investigator-judged unsuitable situations for enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beijing Tiantan Hospital

Beijing, China

Actively Recruiting

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Research Team

N

Ning Ma, MD

CONTACT

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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