NCT03901079

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed 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).

Conditions

• CAD

Interventions

Type	Name	Description
OTHER	single-arm study	single-arm study

Timeline

• Start date: 2018-10-08
• Primary completion: 2020-01-10
• Completion: 2021-03-24
• First posted: 2019-04-03
• Last updated: 2023-12-08
• Results posted: 2023-12-08

Locations

1 site across 1 country: China