CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 147 enrolled
Drug / intervention
Recanalization of a coronary chronic total occlusiondevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00886899
NCT00886899Phase 2Completed
CompareCT.gov

Facilitated Antegrade Steering Technique in Chronic Total Occlusions

BridgePoint Medical·interventional·Posted Apr 23, 2009·Updated Mar 20, 2012

In Brief

A Phase 2 clinical trial evaluating Recanalization of a coronary chronic total occlusion for Coronary Artery Chronic Total Occlusion. Completed, enrolled 147 participants across 16 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Chronic Total Occlusion
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 23, 2009
Enrollment StartMar 1, 2009
Primary CompletionAug 1, 2010
Study CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.2 years ago

Interventions

Recanalization of a coronary chronic total occlusiondevice

Crossing a CTO to allow definitive treatment via balloon angioplasty and/or stent placement