News | FFR Technologies | January 12, 2017

Enrollment Complete for ACIST-FFR Multi-Center Study

Twelve-site study will compare measurement accuracy, drift and device success of Navvus catheter to commercially available pressure guide wire

ACIST-FFR Study, enrollment complete, Navvus catheter, fractional flow reserve

January 12, 2017 — Acist Medical Systems Inc. announced that enrollment is complete for its Fractional Flow Reserve (FFR) Study – Assessment of Catheter-based Interrogation and Standard Techniques for Fractional Flow Reserve measurement. The study, which began in November 2015, included 240 patients at 12 sites across the United States. Final results are expected to be released in mid-2017.

The purpose of this large, prospective, multi-center study is to advance the clinical understanding of FFR technologies by comparing FFR measurements obtained using the Navvus catheter to those obtained using a commercially available pressure guide wire. The co-principal investigators are Matthew Price, M.D., Scripps Clinic, La Jolla, Calif., and William Fearon, M.D., Stanford University, Palo Alto, Calif.

"We are excited about the completion of enrollment in this important clinical trial," said Fearon. "We look forward to analyzing the data to better understand how we can most effectively utilize this exciting technology to help our patients."

The study is specifically evaluating measurement accuracy, incidence of drift, and device success in patients with single or multi-vessel coronary artery disease where FFR is clinically indicated. The results of the study, combined with the ACCESS-NZ Trial results, will provide important data regarding how this technology impacts patient care while demonstrating its clinical usefulness in everyday practice. ACIST FFR will also evaluate measurement accuracy in vessels as small as 2.25 mm.

For more information:

Related Content

American College of Cardiology Expands Patient Navigator Program
News | Cath Lab | March 21, 2018
March 21, 2018 — Hundreds of hospitals across the United States will have access to tools and resources to help impro
Videos | Cath Lab | March 15, 2018
A discussion with Hitinder Gurm, M.D., MBBS, FACC, professor, internal medicine, and associate chief clinical officer
News | Cath Lab | February 27, 2018
The American College of Cardiology (ACC) and the Saudi Arabian Cardiac Interventional Society have partnered to...
News | Cath Lab | February 23, 2018
February 23, 2018 — CorFlow Therapeutics AG announced that the company will present new insights into the coronary mi
Teleflex Launches Next-Generation Sympro Elite and Expro Elite Snares
Technology | Cath Lab | February 07, 2018
Teleflex Inc. has announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and U.S. commercial launch...
SCAI Advocacy Committee Highlights Reimbursement Reform Efforts in 2017
News | Cath Lab | January 30, 2018
The Society for Cardiovascular Angiography and Interventions (SCAI) highlighted the efforts of its Advocacy Committee...
IAC Releases Cardiovascular Catheterization Accreditation Program
News | Cath Lab | January 25, 2018
January 25, 2018 – The Intersocietal Accreditation Commission (IAC) announced the release of its Cardiovascular Cathe
Videos | Cath Lab | January 04, 2018
Bernadette Speiser, BSN, MSN, CCRN, RCIS, a cardiac cath/EP nurse at Palo Alto Veterans Hospital, Palo Alto, Calif.,
FDA Initiates Class I Recall of Sterilmed Reprocessed Agilis Steerable Introducer Sheath
News | Cath Lab | January 04, 2018
The U.S. Food and Drug Administration (FDA) announced a Class I recall of Sterilmed’s Agilis Steerable Introducer...
The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA atherectomy system. Athar Ansari, M.D.

The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA system. 

Feature | Cath Lab | November 24, 2017 | Athar Ansari, M.D., FACC
As debates about the current state and future of healthcare rage in Congress, the media and healthcare settings acros
Overlay Init