The ALL-RISE Study
Research type
Research Study
Full title
Advancing Cath Lab Results with FFRangio® Coronary Physiology Assessment: The ALL-RISE Study
IRAS ID
339740
Contact name
Ramin Mousavi
Contact email
Sponsor organisation
CathWorks Inc.
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IL-MF-000021861, SRN ID
Duration of Study in the UK
1 years, 5 months, 1 days
Research summary
Coronary heart disease is a common condition among older people. Coronary angiography is routinely performed in patients suspected of having coronary artery disease, for diagnostic purposes before, during and after surgery. The fractional flow reserve (FFR) index is calculated for clinical decision-making regarding the treatment of an injury resulting in decreased blood flow in the heart. International guidelines recommend using FFR to guide the treatment strategy for stable coronary lesions.
Standard guidewire-based FFR techniques require the use of invasive devices (penetrating your body) and vasodilation treatment (widening of blood vessels). Similar to standard FFR, CathWorks FFRangio® image-based software provides quantitative analysis of blood flow in your coronary vessels. CathWorks FFRangio® technology does not require the use of additional invasive devices or additional vasodilation treatment.
Standard wire-based FFR as well as CathWorks FFRangio® systems are commercially approved. This means that clinical studies have been conducted to analyze the safety and effectiveness of their use and regulatory authorities have approved their use in the respective markets.
This study is designed as a head-to-head comparison between standard pressure-guided FFR treatment and FFRangio®-guided treatment through independent, randomized assignment into the two treatment arms (like flipping a coin) . The main objective is to verify whether FFRangio®-guided treatment is “non-inferior” to the reference standard pressure wire-guided treatment with regard to safety aspects. “Non-inferior” means that the aim of the study is to demonstrate that the new treatment is at least as effective as the standard treatment. The study does not seek to prove that the new treatment is better, but rather that it is not worse. This has not been demonstrated by other studies before.
Other objectives focus on analyzing hospital resources and costs for the two treatment groups.REC name
HSC REC A
REC reference
24/NI/0115
Date of REC Opinion
14 Oct 2024
REC opinion
Further Information Favourable Opinion