US-based medical device company Abiomed has enrolled the first patient in PROTECT IV, a multi-centre randomised controlled trial (RCT) using its Impella devices.
The trial is designed to provide clinical evidence required to achieve a Class I guideline recommendation for Impella in high-risk percutaneous coronary intervention (HRPCI).
The Impella 2.5 and Impella CP devices are approved in the US to treat certain advanced heart failure patients undergoing percutaneous coronary interventions (PCI).
Also, FDA approved the Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, and Impella 5.5 with SmartAssist to treat a heart attack.
Cardiologists Dr. Ted Schreiber and Dr. Amir Kaki enrolled the first patient at Ascension St. John Macomb-Oakland Hospital.
Dr. Schreiber said: “This trial aims to generate the highest level of scientific clinical evidence to definitively demonstrate that Impella-supported PCI improves outcomes for high-risk patients, and we are excited to enrol the first patient in the trial.
“Dr. Kaki and I are proud of the entire team at Ascension St. John Hospital for being at the forefront of cardiovascular research in this landmark RCT.”
The PROTECT IV study aims to enrol 1,252 consecutive qualified patients at more than 100 hospital sites across the US and Europe.
The two-arm study will compare the benefits of HRPCI with Impella compared to HRPCI without Impella support.
Composite of all-cause death, stroke, myocardial infarction (MI) or hospitalisation for cardiovascular (CV) causes at a minimum of one year is the primary endpoint of the study.
The PROTECT IV RCT is designed to use advancements in technology and best practices learned from the PROTECT II RCT and the FDA pre-market approval (PMA) for Impella 2.5.
In the study, Impella-supported PCI has demonstrated superior levels of optimal and complete revascularisation, which results in improved long-term survival and quality of life.
PROTECT IV principal investigator Dr. Gregg Stone said: “PROTECT IV is a landmark trial with the potential to revolutionize the interventional treatment of patients with complex coronary artery disease and left ventricular dysfunction.
“This academically led study is designed to provide the highest level of robust evidence to guide management and improve global clinical outcomes for these high-risk patients.”
