Imaging Endpoints for a Coronary Stent IDE

Challenge

An investigational device exemption trial for a novel coronary stent required quantitative angiographic endpoints—late lumen loss, percent diameter stenosis, and binary restenosis—measured with enough precision to detect clinically meaningful differences between study arms. Intravascular imaging substudies using IVUS and OCT added further complexity, demanding consistent pullback technique and frame selection. The sponsor needed a core lab whose measurements would withstand FDA's scrutiny of pivotal device data.

Our Solution

Intrinsic Imaging performed quantitative coronary angiography using validated edge-detection software with cardiologist oversight of every measurement, applying standardized frame selection and calibration procedures across all sites. IVUS and OCT pullbacks underwent central quality review for acquisition adequacy before analysis, and volumetric measurements followed a pre-specified analysis plan with blinded replicate reads to quantify measurement variability. All endpoint data were documented in an audit-ready format aligned with the trial's statistical analysis plan.

Results

• Late lumen loss measured with 0.12 mm precision
• Pivotal endpoint data accepted without FDA measurement queries
• IDE approval supported by core lab dataset