A efficacy and safety study on proximal occlusion device for carotid stent placement

Not Applicable

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0000806
• Lead Sponsor: Samsung Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Older than 20 years
- A stenosis over 80% in asymptomatic carotid artery, as determined by NASCET method
- A stenosis over 70% in the symptomatic carotid artery
- A stenosis over 50% & under 70% in the symptomatic carotid artery with difficult anatomy during endarterectomy, high-risk to surgery, or ulceration

Exclusion Criteria

- Modified Rankin score of 3 or more
- Emergency stenting during the thrombolysis in hyperacute stroke
- The patient’s intolerance during the proximal balloon occlusion
- Nonatherosclerotic carotid disease
- Previous revascularization of the symptomatic stenosis
- History of bleeding disorder
- Uncontrolled hypertension or diabetes
- Unstable angina
- Contraindication to antiplatelet or anticoagulation
- Vascular variation or diseases those cannot install the device

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of subjects who show new brain lesion on diffusion MRI that is acquired after carotid stenting

Secondary Outcome Measures

Name	Time	Method
Device success;Procedural success;major complication (stroke, myocardiac infarction, death by cerebrovascular disease)