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Coronary Crossing System in Patients With Coronary Chronic Total Occlusions — VITAL  

Chronic Total Occlusion of Coronary Artery Clinical Trial

Official title:
A Prospective, Multicenter Clinical Trial in Evaluating the Safety and Efficacy of the Coronary Crossing System in Patients With Coronary Chronic Total Occlusions

Clinical Trial Summary

This is a prospective and multicenter clinical investigation aiming to evaluate the safety and effectiveness of coronary crossing system for the treatment of patients with coronary chronic total occlusions.

Clinical Trial Description

This study is divided into two phases. The first phase is the pilot study stage, which is a prospective single-group observational test (FIM phase). The second phase is the pivotal study phase, which is a prospective, multi-center, single-group clinical trial (OPC phase). It is carried out in about 20 hospitals in China. 1. Pilot study phase (FIM phase): It is a prospective single-group observational test. It is expected to recruit 10 subjects in a research center in China. 2. Pivotal study phase (OPC phase): It is a prospective, multicenter, single-group clinical trial. 146 subjects are expected to be recruited in 20 research centers in China. 3. All subjects with coronary chronic total occlusions participating in this clinical study must have only a CTO lesion which occluded in length of more than 5 mm and located in a native coronary artery with a diameter of ≥ 2.50 mm (visual inspection). 4. All subjects receive clinical follow-up during hospitalization, 30 days after surgery. ;

Study Design

Related Conditions & MeSH terms

  • Chronic Total Occlusion of Coronary Artery
Clinical Trial Details
NCT number NCT05813704
Study type Interventional
Source Shanghai MicroPort Rhythm MedTech Co., Ltd.
Contact Tingting Wu, M.D.
Phone 0086-021-38954600
Email TingTing.Wu2@microport.com
Status Recruiting
Phase N/A
Start date November 7, 2023
Completion date May 2025
View Details
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