DES and Medical Treatment for ICAD Trial

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the RCT trial is to evaluate whether implantation of drug-eluting stent (DES) combined with aggressive medical treatment is more efficacious in prevention of composite event of any stroke and death within 30 days after enrollment and ischemic stroke in the territories of the responsible artery from 31 days to 1-year after enrollment than optimal medical treatment for symptomatic intracranial atherosclerotic stenosis.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tiantan Hospital
• Treatments: Sirolimus

Criteria

Inclusion Criteria:

1. Age from 18 to 85 years

2. Patients with stroke within 30 days of enrollment attributed to 70% to 99% stenosis of a major intracranial artery (carotid artery, MCA stem [M1], vertebral artery, or basilar artery) on Computer Tomography angiography (CTA) (According to WASID method)

3. The diameter of the target vessel is between 2.0mm-4.5mm

4. Target area of stenosis is ≤14 mm in length

5. Baseline mRS score ≤3

6. Patient understands the purpose and requirements of the study, can make him/herself understood, and has provided informed consent

Exclusion Criteria:

1. Patients with stroke within 7 days before enrollment.

2. Tandem extracranial or intracranial stenosis (70%-99%) or occlusion that is proximal or distal to the target intracranial lesion (NOTE: anexception is allowed if the occlusion involves a single vertebral artery proximal to a symptomatic basilar artery stenosis and the contralateral vertebral artery is supplying the basilar artery)

3. Patients with stroke caused by perforating artery occlusion

4. CT angiographic evidence of severe calcification at target lesion

5. Any history of brain parenchymal or other intracranial subarachnoid, subdural or extradural hemorrhage in the past 6 weeks

6. Intracranial artery stenosis caused by non-atherosclerotic lesions, including:

arterial dissection, moya-moya disease, vasculitis disease, herpes zoster, varicella-zoster or other viral vascular diseases, neurosyphilis, any other intracranial infections, any intracranial stenosis related to cerebrospinal fluid cells, radiation-induced vascular disease, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, central nervous system benign vascular disease, postpartum vascular disease, suspected vasospasm, suspicious embolism recanalization, etc

7. History of stenting or angioplasty of an intracranial artery;

8. Presence of any unequivocal cardiac source of embolism;

9. Combined with intracranial tumor, aneurysm or intracranial arteriovenous malformation

10. Those who cannot tolerate general anesthesia due to insufficiency of cardiac or pulmonary function

11. Patients who cannot receive dual antiplatelet therapy due to existing diseases or are tolerant to dual antiplatelet therapy confirmed by relevant test

12. Patients with known severe hepatic and renal dysfunction

13. Patients with known severe allergies or contraindications to heparin, paclitaxel, contrast agents and other related intravascular treatment drugs

14. Patients with hemoglobin<100g/L, platelet count<100×1,000,000,000/L, INR>1.5 or there are uncorrectable factors leading to bleeding (if there are multiple checks, the last one shall prevail)

15. Major surgery (including open femoral artery, aortic or carotid artery surgery) within the past 30 days or planned within 90 days

16. Patients with renal artery, iliac artery, and coronary artery requiring simultaneous intervention

17. Life expectancy <1 year

18. Pregnant or lactating women

19. Patients who cannot complete the follow-up due to cognitive, emotional or mental illness

20. According to the judgement of the investigator, other situations that are not suitable for enrollment

21. Enrollment in another study that would conflict with the current study