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Clinical Research of Surgical Treatment for Symptomatic Moderate to Severe Carotid Artery Stenosis Caused by Different Types of Atheromatous Plaque

Clinical Research of Surgical Treatment for Symptomatic Moderate to Severe Carotid Artery Stenosis Caused by Different Types of Atheromatous Plaque

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-16009519
Enrollment
Unknown
Registered
2016-10-20
Start date
2017-01-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

carotid artery stenosis

Interventions

CEA group:On the basis of regular medical treatment of internal medicine, the patients were given CEA treatment. The CEA operation would be performed under general anesthesia, with shunt or artery pat
CSA group:On the basis of regular medical treatment of internal medicine, the patients were given CSA treatment. The CSA treatment would be performed under local anesthesia, with distal filter protect

Sponsors

Renji Hospital (South Campus), Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: Clnincal setting: 1. In half year, patients with amaurosis, ischemic stroke or transient ischemic attack caused by internal carotid artery stenosis; 2. MRS score<3; 3. Male and female aged 50-80 years; 4. To be willing and able to provide written informed consent/assent for the trial. Vascular conditions: According to cerebral angiography result,the degree of carotid artery stenosis is 50-99%, and the stenosis location is in the common carotid artery, carotid bifurcation or internal carotid artery. Neurosurgeon believe that two surgical methods, CEA and CSA are appropriate.

Exclusion criteria

Exclusion criteria: Clnincal setting: 1. Intracranial hemorrhage in 3 months; 2. Hypertension is not effectively controlled; 3. Pregnant or lactating patients; 4. Accompany by intracranial vascular malformations or aneurysms at the same time; 5. Accompany by other serious diseases, the estimated survival time is less than 2 years; 6. Have coagulation disorders; 7. Have contraindication of heparin, aspirin and clopidogrel; 8. Have contraindication of contrast medium; 9. Have another surgical plan. Vascular conditions: 1. Common carotid artery or carotid artery occlusion; 2. Carotid stenosis due to external compression; 3. Carotid stenosis due to arterial dissection; 4. Restenosis after surgery or stenting; 5. Carotid stenosis induced by radiation; 6. Carotid stenosis due to the dysplasia of muscular fibers; 7. Active thrombus; 8. Simultaneous presence of intracranial artery stenosis or contralateral carotid stenosis. In addition, 1) patients who were participating in other clinical trials; 2) the researchers considered other reasons not suitable for clinical trials.

Design outcomes

Secondary

MeasureTime frame
Carotid ultrasound examination;Cerebral angiography;

Primary

MeasureTime frame
Neurological assessment NIHSS score;High resolution multi modality MR examination to assess the carotid plaques and brain;

Countries

China

Contacts

Public ContactDai Jiong

Renji Hospital (South Campus), Shanghai Jiaotong University School of Medicine

daijiong@126.com+86 13701714033

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026