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Trial for A Novel Facilitated Antegrade Steering Technique in Revascularization of Coronary Chronic Total Occlusions

CAD Clinical Trial

Official title:
A Prospective, Multi-center, Non-Randomized Controled Trial for A Novel Facilitated Antegrade Steering Technique in Revascularization of Coronary Chronic Total Occlusions In Chinese Population--FAST CTO China

Clinical Trial Summary

To assess the safety and efficacy of the BridgePoint CTO system in recanalization of CTO lesions which are resistant to a conventional wire approach in a multicenter study in Chinese population

Clinical Trial Description

All subjects who are candidates for percutaneous coronary intervention (PCI), signed the informed consent form and had chronic total coronary occlusion (CTO) lesion will be evaluated for enrollment in this study.At least 100 subjects will be enrolled. Each site will be allowed to enroll up to a maximum of 25 subjects. Primary Effectiveness Endpoint: Technical Success: the ability of the BridgePoint Medical System to successfully facilitate placement of a guidewire beyond a CTO lesion in the true vessel lumen/within the collaterals in those cases that were otherwise refractory to treatment with a currently marketed guidewire Primary Safety Endpoint: 30-day MACE rate for CTO cases in which the BridgePoint Medical System was used. MACE is defined as the composite of cardiac death, Q-wave and non-Q-wave myocardial infarction(MI), and any ischemia-driven target lesion revascularization(TLR). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03901079
Study type Observational
Source Boston Scientific Corporation
Contact
Status Terminated
Phase
Start date October 8, 2018
Completion date March 24, 2021
View Details
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