At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Scoreflex NC - Scoring PTCA Catheter: A Prospective, Open Label, Multi-center, Single Arm, Observational Study Designed to Evaluate the Safety and Device Procedural Success of the Scoreflex NC Scoring PTCA Catheter in Subjects With Stenotic Coronary Arteries During Percutaneous Coronary Intervention.
In Brief
A clinical study evaluating Scoreflex NC Scoring PTCA catheter for Coronary Artery Disease and 5 related conditions. Completed, enrolled 200 participants across 9 sites.
Detailed Summary
A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device procedural success of the Scoreflex NC Scoring Percutaneous Transluminal Coronary Angioplasty (PTCA) catheters in subjects with stenotic coronary arteries during percutaneous coronary intervention. Two-hundred (200) subjects will be treated at up to 15 U.S. sites with the Scoreflex NC Scoring PTCA catheter during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through hospital discharge.
Study Details
Timeline
Interventions
To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters