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

A efficacy and safety study on proximal occlusion device for carotid stent placement: using diffusion weighted image

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0000806

Enrollment

200

Registered

2013-07-24

Start date

2013-07-31

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Medical Device : Carotid Artery Stenting with cerebral protection with the MO.MA device

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Number of subjects who show new brain lesion on diffusion MRI that is acquired after carotid stenting	—

Secondary

Measure	Time frame
Device success;Procedural success;major complication (stroke, myocardiac infarction, death by cerebrovascular disease)	—

Countries

Korea, Republic of

Contacts

Public ContactChang-Woo Ryu

Kyung Hee University Hosipital at Gangdong

Outcome results