Status:
UNKNOWN
Comparison of Staged Angioplasty and Routine Single-stage Stenting (CAS) in the Treatment of Carotid Artery Stenosis
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Carotid Artery Stenosis
Eligibility:
All Genders
40-80 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of staged carotid angioplasty v.s. routine single-stage carotid artery stenting in Chinese patients with carotid artery stenosis at hig...
Detailed Description
1. Data Quality Before the initiation of the study sites, Cerebrovascular Disease Center of Beijing Tiantan Hospital will verify whether the investigators are qualified, inspect the study site's f...
Eligibility Criteria
Inclusion
- Patient must be 40\~80 years of age
- Patient with symptomatic carotid stenosis (defined as stroke/TIA of the patient within 90 days while he/she is taking at least one antithrombotic drug or under other intervention on vascular risk factors like hypertension or hyperlipidemia)
- DSA shows percent carotid stenosis≥90% (quantification of the stenosis according to NASCET method); or near occlusion
- Angiogram shows insufficient collateral circulation in the culprit vessel surrounding area:
- Cerebral CT perfusion imaging shows hypo-perfusion of the culprit vessel surrounding area, and
- DSA shows collateral circulation assessment \< 2, and
- MRI cerebral imaging shows hemodynamic ischemic lesion
- CT perfusion imaging shows cerebral blood flow of the culprit side is of 20% lower than the other lateral brain
- Lesion length at the narrowest part \< 25mm
- Note: Grading of angiographic collateral circulation
- Grade 0: No collateral circulation in the area dominated by the culprit vessel
- Grade 1: Slow collateral circulation in the surrounding areas, but filling defects exist
- Grade 2: Fast collateral circulation, but some areas still have filling defects
- Grade 3: Collateral circulation is slow, but complete filling can be seen in the vein at a late stage
- Grade 4: Complete and fast collateral circulation, without any filling defect
Exclusion
- Diffusive stenosis of the cerebral artery
- MRI cerebral imaging shows perforating artery occlusion
- Cerebral hemorrhage at the culprit vessel surrounding area within 6 weeks; potential thrombus from the heart
- Subsequent cerebral tumor, cerebral aneurysm, or arteriovenous abnormality
- Known contraindication to heparin, aspirin, ticlopidine, a aesthetic, and contrast; blood hemoglobin \< 10g/dl, blood platelet \< 100000
- Severe nerve dysfunction in the culprit vessel surrounding area after a cerebral infarction (mRS≥3)
- INR \> 1.5 (irreversible), uncorrectable bleeding risk factors, life expectancy \< 1 year
- Women in pregnant or breast feeding
- Committee adjudicating the inclusion criteria finds the patient is unsuitable for the staged angioplasty for carotid artery stenosis
- Unsuccessful placement of proximal or distal EPD during the procedure
- The target vessel angle≧45
- Participate in other clinical trials within three months
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2017
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT02224209
Start Date
November 1 2014
End Date
September 1 2017
Last Update
November 17 2014
Active Locations (1)
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1
Beijing Tian Tan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050