NCT06864299

Study on the Trans-Carotid Artery Occlusion Shunt System Combined With Introducer Sets

Study on the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System Combined With Introducer Sets for Cerebral Protection During Carotid Angioplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Shenzhen Wecan Medical Technology Co.,Ltd · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to evaluate the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets for Cerebral Protection During Carotid Angioplasty

Detailed description

The physician shall strictly follow the clinical study protocol and shall not deviate from or substantially change the protocol. However, in case of emergency such as immediate risk to the subjects, which needs tobe eliminated immediately, it may be reported in written form afterwards. During the course of the study,documents such as amendments to the clinical study protocol and informed consent, requests for deviation,and resumption of the suspended clinical study shall be subject to the written approval of the Ethics Committee

Conditions

• Carotid Artery Stenosis
• Carotid Artery Diseases

Interventions

Type	Name	Description
DEVICE	Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets	To evaluate the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets for Cerebral Protection During Carotid Angioplasty

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2025-03-07
• Last updated: 2025-07-11

Locations

1 site across 1 country: China