NCT05893498

Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,924 (estimated)
• Sponsor: CathWorks Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To test whether FFRangio-guided treatment is non-inferior to conventional pressure wire-guided treatment in patients with coronary artery disease.

Detailed description

ALL-RISE is a prospective, randomized, multi-center, controlled post-market study. The ALL-RISE study is designed to test whether FFRangio-guided treatment is non-inferior to conventional pressure wire-guided treatment in patients with coronary artery disease being evaluated for percutaneous coronary intervention (PCI) with respect to major adverse cardiac events (MACE) at one year.

Conditions

• Percutaneous Coronary Intervention

Interventions

Type	Name	Description
DEVICE	FFRangio	A 3D image-base software device (CathWorks, Ltd, Kfar Saba, Israel) using three (3) angiographic views to provide a quantitative analysis of the functional significance of coronary lesions.
DEVICE	FFR or NHPR	Using an invasive pressure-wire to assess functional significance of coronary lesions either under hyperemic conditions (FFR) or utilizing Non-hyperemic pressure ratios (NHPR).

Timeline

• Start date: 2023-06-21
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2023-06-08
• Last updated: 2026-03-10

Locations

59 sites across 5 countries: United States, Israel, Japan, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study