MedTrace Logo

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

NCT00886899 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2012-03-20

Study results available
· View outcomes & findings →

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

DEVICE

Recanalization of a coronary chronic total occlusion

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

Sponsors & Collaborators

  • BridgePoint Medical

    lead INDUSTRY

Principal Investigators

  • Patrick Whitlow, MD · The Cleveland Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-08-31
Completion
2010-09-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00886899 on ClinicalTrials.gov