Paris, France - On May 17, CRO hosted the opening ceremony for the study INSIGHTFUL-FFR, a prospective, multi-center, randomized controlled trial on assessing the clinical outcomes of TruePhysio® pressure microcatheter-guided PCI compared with that guided by pressure wire. Around 30 investigators from different participating centers attended the ceremony.
The study is led by principal investigator Dr. Emanuele Barbato (Cardiovascular Center Aalst, Belgium), together with the co-principal investigators Dr. Salvatore Brugaletta (Hospital Clinic, Barcelona, Spain), Dr. Junbo Ge (Zhongshan Hospital, Fudan University, Shanghai, China) and Dr. Carlos Collet (Cardiovascular Center Aalst, Belgium), and Dr. Bernard De Bruyne (Cardiovascular Center Aalst, Belgium) as the chairperson of the steering committee.
At the beginning, Dr. Carlos Collet gave the opening presentation to introduce the definition of INSIGHTFUL-FFR, the principal investigators, and the cooperative institutions.
Then Dr. Liang Song, Co-Founder & CEO of Insight Lifetech, delivered a welcome speech. According to Dr. Song, Insight Lifetech has been dedicated to developing innovative solutions that make the interventional treatment of cardiovascular diseases more precise and easier. The TruePhysio® pressure microcatheter is a new rapid-exchange FFR tool that is extremely easy-to-use in various clinical scenarios. Hopefully, through the INSIGHTFUL-FFR study, more physicians and patients can be benefited by a rapid and simplified FFR-guided PCI procedure enabled by this new tool.
Afterwards, Dr. Junbo Ge made a presentation introducing the unmet clinical needs in FFR measurement with traditional pressure wire and introduced TruePhysio® microcatheter, which is more user-friendly. He also shared the previous clinical study SUPREME, and the ongoing SUPREME II study, both of which involve TruePhysio®.
Dr. Emanuele Barbato and Dr. Salvatore Brugaletta then briefly introduced the protocol of the INSIGHTFUL-FFR study, including the study hypothesis that the use of pressure microcatheter for clinical decision making and PCI guidance would be non-inferior to pressure wire-based strategy with respect to the risk of major adverse clinical outcomes, the use of microcatheter-based FFR stent optimization is superior to pressure wire-based FFR in terms of resource utilization. The inclusion and exclusion criteria, the study endpoints and the study flowchart were also introduced.
After that, a recorded case showing how TruePhysio® pressure microcatheter was used pre-and post-PCI.
Investigators showed great enthusiasm towards the superiority of TruePhysio® and expectations of the INSIGHTFUL-FFR study. Just as Dr. Emanuele Barbato said, “We start with new enthusiasm, we start with a new idea and we start an innovative approach, we start with a new trial. Yet we also try to get with us what we have done in the past, try to improve it in the next years.”
With the increasing clinical applications, TruePhysio® will potentially simplify the PCI workflow,especially in multi-vessel disease and bifurcation lesions, and improve the pullback and post-PCI assessment, as to transform healthcare for more patients globally.
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