Drug coated balloon Angioplasty vs Stenting for symptomatic Intracranial Stenosis trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000031335

Enrollment

Unknown

Registered

2020-03-27

Start date

2020-04-01

Completion date

Unknown

Last updated

2020-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Stenosis

Interventions

DCB group:Drug coated balloon Angioplasty

Control group:Stenting

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged >=20 years; 2. Recurrent TIA or stroke attributed to 70-99% stenosis of an intracranial artery in past 6 months; 3. Ineffectiveness of medical therapy for stroke prevention; 4. Target lesion with a normal diameter larger than 2.0 mm and less than 4.5 mm, lesion length is less than 14 mm; 5. Modified Rankin Score 0-3; 6. The patient is willing and able to return for all follow-up visits required by the protocol; 7. The patients understands the purpose and requirements of the study and has provided informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with intracranial non atherosclerotic stenosis, including arterial dissection, moyamoya disease, angioinflammatory disease, angiopathy caused by radiotherapy, myofibrous dysplasia, etc; 2. Serial stenosis: severe stenosis of extracranial segment in the proximal part of intracranial artery stenosis; 3. Previous treatment of target lesion with stenting or angioplasty; 4. Pregnancy; 5. Patients with antiplatelet drugs or iodine containing contrast agents contraindications; 6. With uncontrolled severe hypertension: systolic pressure >180mmHg or diastolic pressure >115mmHg 7. With severe liver injury: AST or ALT exceeds the normal value by 3 times; 8. With severe renal insufficiency: Creatinine >=265umol/l; 9. Combining other diseases with a life expectancy of less than 3 years; 10. Patients who have been included in other studies and conflict with this study.

Design outcomes

Primary

Measure	Time frame
Binary Restenosis Rate;	—

Secondary

Measure	Time frame
Any stroke (ischemic, parenchymal brain hemorrhage, subarachnoid or intraventricular hemorrhage) or death within 30 days after enrollment;an ischemic stroke in the territory of the symptomatic intracranial artery;Symptomatic restenosis rate;	—

Countries

China

Contacts

Public ContactHu Shen

Beijing Hospital

hustyle@126.com+86 15600027009

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026