Using drug-coated balloons to treat intracranial in-stent restenosis

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

This study is testing if drug-coated balloons can better treat patients with intracranial in-stent restenosis compared to regular balloons.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Acotec Scientific Co., Ltd (Industry-sponsored)
• Locations: 1 site (Beijing)
• Trial ID: NCT04627870 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and feasibility of using drug-coated balloons, specifically paclitaxel-coated balloons, in treating intracranial in-stent restenosis (ISR). It is a prospective, multi-center, randomized controlled trial comparing the effectiveness of drug-coated balloons against uncoated percutaneous transluminal angioplasty (PTA) balloons. The trial aims to determine if the drug-coated approach can improve outcomes for patients suffering from ISR in various intracranial arteries.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with confirmed intracranial in-stent restenosis and associated ischemic symptoms or severe hypoperfusion.

Not a fit: Patients without significant in-stent restenosis or those who do not meet the specific inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of stroke and improve blood flow in patients with intracranial atherosclerosis.

How similar studies have performed: Other studies have shown promise with drug-coated balloons in vascular interventions, suggesting potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

* 18 to 80 years of age
* Confirmed by DSA: in-stent restenosis (ISR) at intracranial segment of internal carotid artery, middle cerebral artery, basilar artery and vertebral artery; ISR is defined as \>50% stenosis within or immediately adjacent (within 5 mm) of the implanted stent and \>20% absolute luminal loss
* presence of ISR associated ischemic stroke or transient ischemic attacks even with medical treatment and strict control of risk factor
* asymptomatic ISR with severe hypoperfusion in the ISR territories, confirmed by a cerebral blood flow decrease of ≥30% when compared with the perfusion on the contralateral side for anterior circulation lesions or the anterior circulation territory for posterior circulation lesions on CT perfusion, and/or by an American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology (ASITN/SIR) Collateral Flow Grading System score \<3 on DSA.
* the diameter of target vessel is 2.0-4.5mm
* there is only one intracranial ISR lesion per subject
* baseline mRS score ≤2
* Voluntarily participate in this study and sign the informed consent form

Exclusion Criteria:

* Patients with stroke within 2 weeks before procedure;
* any history of brain parenchyma or other intracranial subarachnoid, subdural or extradural hemorrhage in the past 30 days.
* Those who have received thrombolysis within 24 hours before procedure;
* Deterioration of neurological function within 24 hours before procedure (defined as NIHSS score increased by ≥ 4 points over the baseline)
* patients with thrombus in target vessels.
* in addition to ISR lesions, there are other primary intracranial lesions that need endovascular treatment.
* Major surgery (including open femoral, aortic or carotid artery surgery) is planned within the past 30 days or within 90 days.
* patients with renal artery, iliac artery and cardiac coronary artery requiring simultaneous intervention.
* Combined with intracranial tumors, aneurysms or intracranial arteriovenous malformations.
* Cardiac stroke or potential cardiogenic thromboembolism, with any of the following cardiogenic embolism causes: chronic or paroxysmal atrial fibrillation, mitral valve stenosis, mechanical valves, endocarditis, intracardiac thrombus or implant, dilated cardiomyopathy, spontaneous acoustic imaging of the left atrium;
* patients with myocardial infarction within 6 weeks before procedure.
* those who cannot tolerate general anesthesia due to insufficiency of heart, lung and other important organs.
* patients with known severe hepatic and renal dysfunction.
* patients with hemoglobin \< 100g / L, platelet count \< 100,000 / mm3, INR \> 1.5or with uncorrectable factors leading to bleeding.
* patients who cannot receive dual antiplatelet therapy due to existing diseases or who are tested to be tolerant to dual antiplatelet therapy.
* Patients with known severe allergies or contraindications to heparin, paclitaxel, contrast agents and other related intravascular treatment drugs
* current alcohol or drug abuse, uncontrolled severe hypertension (systolic blood pressure \> 180mmHg or diastolic blood pressure \> 110mmHg).
* Life expectancy \< 1 year.
* pregnant or lactating women.
* patients who are unable to complete follow-up due to cognitive, emotional disorders or mental illness.
* Patients who are participating in other drug/device clinical trials and have not completed all follow-ups required by the programme;
* According to the judgement of the investigator, other situations that are not suitable for enrollment

Where this trial is running

Beijing

• Beijing Tiantan Hospital — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Ning Ma, MD — Beijing Tiantan Hospital
• Study coordinator: Ning Ma, MD

Conditions Intracranial Atherosclerosis; Stroke; In-stent restenosis; drug coated balloon