NCT02689037

Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis

Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis: Study Protocol of a Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 394 (estimated)
• Sponsor: The 476th Hospital of People's Liberation Army · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Background: Effectiveness of Percutaneous transluminal angioplasty and stenting (PTAS) on prevention of events of stroke and death in patients with symptomatic intracranial atherosclerosis (ICAS) is controversial. Aim: to determine whether PTAS plus medical treatment (MT) are superior to MT alone in preventing events of stroke and death in patients with symptomatic ICAS. Methods: The investigators will carry out a randomized controlled trial in 3 hospitals in China. A total of 198 patients with ICAS will be randomized into 2 groups: PTAS+MT and MT group. All patients will receive aspirin (100 mg daily) and clopidogrel (75 mg daily) immediately after randomization, and patients in PTAS+MT group will receive surgery within 5 days after randomization. The patients will be followed up for 1 year after randomization and assessed for events of stroke and death at 30 days and 1 year after randomization, the incidence of recurrent ischaemic stroke in the stenting-involved vascular territory at 30 days and 1 year after randomization, incidence of in-stent restenosis at 1 year after randomization,etc.

Conditions

• Intracranial Atherosclerosis

Interventions

Type	Name	Description
PROCEDURE	Percutaneous transluminal angioplasty and stenting	Surgeons will plant stents after vascular angioplasty in target ICAS vessels within 5 days after randomization.
DRUG	Aspirin plus clopidogrel	aspirin 100mg daily and clopidogrel 75mg daily for 90 days

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-12-01
• Completion: 2019-12-01
• First posted: 2016-02-23
• Last updated: 2016-04-05