Multi-Center Study of a Novel Vascular Device

Challenge

A multi-center study of a novel vascular device required imaging assessment of deployment, device position and vessel response over follow-up. Vascular device surveillance combines angiographic measurements at the procedure with CT angiography and duplex ultrasound thereafter, and each modality measures vessel dimensions differently, which can produce apparent changes that reflect modality rather than device performance.

The sponsor needed consistent measurement conventions across modalities, a charter that defined deployment success and surveillance endpoints, and interventional radiologists with device experience to interpret findings such as apposition, endoleak-type phenomena, stenosis and thrombus.

Intrinsic Imaging’s Solution

Intrinsic Imaging developed the imaging charter defining acquisition for procedural angiography, CT angiography and duplex ultrasound, together with measurement conventions and endpoint definitions for deployment success, device position, vessel patency and device-related findings. Sites were qualified and trained on each modality with emphasis on reproducible duplex technique.

Board-certified interventional radiologists performed blinded reads of procedural and follow-up imaging under the charter, including 3D reconstruction of CT angiography for device and vessel measurement. Primary endpoint assessments were double-read with adjudication.

Image transfer, quality control and processing were centralized so that each patient's multimodal record was complete and co-registered before reading, and the longitudinal dataset was delivered with modality identified for every measurement.

Intrinsic Imaging’s Results

• Approximately 190 patients at 16 sites assessed across angiography, CT angiography and duplex ultrasound
• Cross-modality measurement conventions applied uniformly with modality recorded for every vessel measurement
• Primary endpoint reader agreement above 90% with adjudication documented for all discordant assessments
• 3D CT angiography reconstruction used for device and vessel measurement at every follow-up with CT