International Phase II Study of a Novel Vascular Device

Challenge

An international Phase II study evaluated a novel vascular medical device, with imaging endpoints covering deployment success, patency and device integrity over follow-up. Sites across several countries used different combinations of procedural angiography, duplex ultrasound and CT angiography, and duplex technique in particular varies widely between vascular laboratories.

The sponsor needed interventional radiologists experienced with the device class to define reproducible endpoints, standardize acquisition across countries, and assess every device image consistently so that Phase II results would support the design of a pivotal trial.

Intrinsic Imaging’s Solution

Intrinsic Imaging's interventional radiology-led device team developed the imaging charter with acquisition requirements for each modality, including a standardized duplex protocol with defined velocity criteria, and endpoint definitions for deployment success, patency and device integrity. Sites were qualified and trained in each country.

Full-time, fellowship-trained interventional radiologists performed blinded reads of all device images against each patient's post-deployment baseline, with double reads on primary endpoints and adjudication of discordant findings.

Image transfer, quality control and processing were centralized, with inadequate duplex studies returned for re-acquisition, and the dataset was delivered with modality identified for every measurement to inform pivotal trial design.

Intrinsic Imaging’s Results

• Approximately 150 patients at 14 sites in 6 countries assessed across angiography, duplex ultrasound and CT angiography
• Standardized duplex protocol with defined velocity criteria adopted at all sites, with inadequate studies reduced to under 6% after training
• Primary endpoint double reads with reader agreement above 90% and documented adjudication
• Endpoint definitions and acquisition standards carried forward by the sponsor into pivotal trial design