Condition category
Circulatory System
Date applied
16/08/2005
Date assigned
04/10/2005
Last edited
01/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.strokecn.com

Contact information

Type

Scientific

Primary contact

Dr Wei-Jian Jiang

ORCID ID

Contact details

No. 6 Tiantan Xili
Beijing
100050
China
+86 1067050137
cjr.jiangweijian@vip.163.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2004BA714B-7

Study information

Scientific title

Acronym

ASSIST–II

Study hypothesis

H0: Adjunctive stenting to optimal medical therapy is not superior to optimal medical therapy alone in reducing ipsilateral stroke risk in patients with symptomatic intracranial atherosclerotic stenoses.
H1: Adjunctive stenting to optimal medical therapy is superior to optimal medical therapy alone in reducing ipsilateral stroke risk in patients with symptomatic intracranial atherosclerotic stenoses.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Ischemic stroke

Intervention

Stent-assisted angioplasty of the offending intracranial stenosis plus optimal medical therapy versus optimal medical therapy alone

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Ipsilateral stroke, fatal or non-fatal, within 12 months
2. Events of clinically-driven emergency revascularization related to the treated stenosis
3. Modified Rankin score in 12 months

Secondary outcome measures

1. Stroke and death unrelated to the target stenosis
2. Acute myocardial infarction in 12 months
3. Follow up cerebral angiography or magnetic resonance (MR) angiography, CT and CT-perfusion in 6 months
4. NIHSS in 12 months

Overall trial start date

01/09/2005

Overall trial end date

30/09/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. 18-75 years of age
2. ≥1 major atherosclerotic risk factors (arterial hypertension, hyperlipidemia, diabetes mellitus, hyperhomocystinemia and smoking)
3. Recurrent ischemic events (transient ischemic attack [TIA] and/or stroke) attributed to an intracranial stenosis ≥50% at digital subtraction angiography (DSA)
4. Evidence of perfusion deficit at the territory referable to the target stenosis in computed tomography (CT)-perfusion
5. The diameters of the parent arteries were between 2.0 to 4.0 mm, and length of stenoses <12 mm
6. Modified Rankin score ≤2 prior to last ischemic event

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

399

Participant exclusion criteria

1. Stenosis of non-atherosclerotic origin (for example, vasculitis, Moya Moya disease and fibromuscular dysplasia)
2. Intracranial hemorrhage and major ischemic stroke (National Institutes of Health-Stroke-Scale [NIHSS] ≥8) in the same hemisphere as the target lesion within 6 weeks
3. A potential source of cardiac embolism
4. Concurrent intracranial tumors, cerebral arteriovenous malformation (AVM) and aneurysms
5. Presence of a neurological illness that can confound the diagnosis of TIA or stroke
6. Known contraindication to aspirin, clopidogrel, probucol, heparin, stainless steel, anesthesia, or X-ray contrast
7. Uncorrectable bleeding diathesis; previous stenting of the target artery
8. A positive pregnancy test
9. Life expectancy <1 year because of other medical conditions
10. Patients were not eligible if they could not cooperate with the study procedures or provide informed consent

Recruitment start date

01/09/2005

Recruitment end date

30/09/2009

Locations

Countries of recruitment

China

Trial participating centre

No. 6 Tiantan Xili
Beijing
100050
China

Sponsor information

Organisation

The Ministry of Health of the People's Republic of China

Sponsor details

No.1 The South Road Of Xizhimenwai
Beijing
100044
China
manluzhu@yahoo.com.cn

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

The Ministry of Health of The People's Republic of China

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes