Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: China Angioplasty & Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS): a New, Prospective, Multi-center, Randomized Controlled Trial in China
Brief Summary: Patients with symptomatic stenosis of intradural arteries are at high risk for subsequent stroke. Since the SAMMPRIS trial, stenting is no longer recommended as primary treatment, however, the results of this trial, its inclusion criteria and its center selection received significant criticism and did not appear to reflect our experience, neither regarding natural history, nor treatment complications rate. As ICAS is the most common cause for stroke in Asian countries, we are hereby proposing a refined prospective randomized multicenter study in an Asian population with strictly defined patient and participating center inclusion criteria.

The China Angioplasty \& Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS) trial, is an ongoing, government-funded, prospective, multicenter randomized trial. It recruits patients with recent TIA or stroke caused by 70-99% stenosis of a major intracranial artery. Patients with previous stroke related to perforator ischemia will not be included. Only high-volume center with a proven track record will enroll patients as determined by a lead-in phase. Patients will be randomized (1:1) to best medical therapy alone or medical therapy plus stenting. Primary endpoints are any stroke or death within 30 days after enrollment or after any revascularization procedure of the qualifying lesion during follow-up, or stroke in the territory of the symptomatic intracranial artery beyond 30 days The CASSISS trial will be conducted in 8 sites in China with core imaging lab review at a North American site and aims to have a sample size of 380 subjects (stenting, 190; medical therapy, 190). Recruitment is expected to be finished by Dec, 2016. Patients will be followed for at least three years. The trial is scheduled to complete in 2019. In the proposed trial, certain shortcomings of SAMMPRIS including patient and participating center selection will be addressed. The present manuscript outlines the rationale and design of the study. We estimate that this trial will allow for a critical reappraisal of the role of intracranial stenting for selected patients in high volume centers.


Options:
A: Arm Label: Intracranial stenting group; Type: EXPERIMENTAL; Interventions: Procedure: Intracranial stenting group | Arm Label: medical group; Type: ACTIVE_COMPARATOR; Interventions: Drug: medical group | Intervention Type: PROCEDURE; Name: Intracranial stenting group; Assigned to Arm(s): Intracranial stenting group | Intervention Type: DRUG; Name: medical group; Assigned to Arm(s): medical group
B: Arm Label: Wingspan Stent System; Type: OTHER; Interventions: Device: Wingspan Stent System | Intervention Type: DEVICE; Name: Wingspan Stent System; Assigned to Arm(s): Wingspan Stent System
C: Arm Label: Carotid Artery Endarterectomy (CEA); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Carotid Endarterectomy (CEA) | Arm Label: Carotid Artery Stenting (CAS); Type: ACTIVE_COMPARATOR; Interventions: Device: Carotid Artery Stenting (CAS) | Intervention Type: PROCEDURE; Name: Carotid Endarterectomy (CEA); Assigned to Arm(s): Carotid Artery Endarterectomy (CEA) | Intervention Type: DEVICE; Name: Carotid Artery Stenting (CAS); Assigned to Arm(s): Carotid Artery Stenting (CAS)
D: Arm Label: Antiplatelet; Type: ACTIVE_COMPARATOR; Interventions: Drug: aspirin, Drug: clopidogrel, Other: placebo | Arm Label: Blood pressure; Type: ACTIVE_COMPARATOR; Interventions: Other: Target of Blood Pressure | Intervention Type: DRUG; Name: aspirin; Assigned to Arm(s): Antiplatelet | Intervention Type: DRUG; Name: clopidogrel; Assigned to Arm(s): Antiplatelet | Intervention Type: OTHER; Name: Target of Blood Pressure; Assigned to Arm(s): Blood pressure | Intervention Type: OTHER; Name: placebo; Assigned to Arm(s): Antiplatelet

Answer: A