NCT00886899

Facilitated Antegrade Steering Technique in Chronic Total Occlusions (FAST-CTOs)

Facilitated Antegrade Steering Technique in Chronic Total Occlusions

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: BridgePoint Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, non-randomized, multicenter study in subjects with coronary artery chronic total occlusions (CTOs). Published results of safety and effectiveness of conventional techniques will be used for comparison. Enrollment of up to 149 subjects with a CTO refractory to currently marketed guidewire use and meeting all inclusion/exclusion criteria at up to 15 US clinical sites. Hypothesis is that the BridgePoint Medical System is safe and effective in treating coronary CTOs compared to CTO literature.

Conditions

• Coronary Artery Chronic Total Occlusion

Interventions

Type	Name	Description
DEVICE	Recanalization of a coronary chronic total occlusion	Crossing a CTO to allow definitive treatment via balloon angioplasty and/or stent placement

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-08-01
• Completion: 2010-09-01
• First posted: 2009-04-23
• Last updated: 2012-03-20
• Results posted: 2012-03-13

Locations

16 sites across 1 country: United States