Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT01763320
Status:
COMPLETED
Last Update Posted:
2022-05-12
First Post:
2013-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
China Angioplasty & Stenting for Symptomatic Intracranial Severe Stenosis
Sponsor:
Xuanwu Hospital, Beijing
Organization:
Study Overview
Official Title:
China Angioplasty & Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS): a New, Prospective, Multi-center, Randomized Controlled Trial in China
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CASSISS
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.
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.
Detailed Description:
Although SAMMPRIS trial has had an impact on the current treatment of intracranial atherosclerotic (ICAS), criticism regarding to its design were still raised and remained unsettled. In light of SAMMPRIS, medical therapy could not be good as it was; neither stenting for ICAD need to be abolished, but rather its role needs to be redefined by future prospective trials. Moreover, China is a developing country, and has the world's largest population. Since 2010, stroke has been the leading cause of death in China and confers a huge burden and effort on patients and health professionals. Compared with western countries, ICAS is the most common vascular lesion in patients with cerebro-vascular disease, and is an important cause of ischemic stroke and future recurrent events in China. However, its treatment strategy and long-term result has not been well determined. The health burden in China and ethnic difference of ICAS incidence as well as the willingness to continue clinical trials, support the need for ongoing CASSISS in China.
Pre-CASSISS registry trial:
A registration pilot trial was performed prior to CASSISS. It aimed to test the credentialing of interventionists and participating centers. From July 2013 to Mar 2014, 12 candidates were involved in a competitive registration study of recruiting 100 consecutive patients. The patients received stenting using Wingspan at each site. As for the candidate centers, the following aspects will be considered: stenting experiences, peri-operative complications, and the volume of stenting cases. Those met the following criteria were not involved into the subsequent randomization trial: 1) each center performed more than 5 procedures; 2) clinical results demonstrated the complication rates were more than 15% (stroke or death). At last, 4 sites were excluded and the remaining 8 were certified and invited for the final randomization trial.
Pre-CASSISS registry trial:
A registration pilot trial was performed prior to CASSISS. It aimed to test the credentialing of interventionists and participating centers. From July 2013 to Mar 2014, 12 candidates were involved in a competitive registration study of recruiting 100 consecutive patients. The patients received stenting using Wingspan at each site. As for the candidate centers, the following aspects will be considered: stenting experiences, peri-operative complications, and the volume of stenting cases. Those met the following criteria were not involved into the subsequent randomization trial: 1) each center performed more than 5 procedures; 2) clinical results demonstrated the complication rates were more than 15% (stroke or death). At last, 4 sites were excluded and the remaining 8 were certified and invited for the final randomization trial.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: