US-based medical device company Shockwave Medical has finished enrolling subjects in the EMPOWER CAD study of percutaneous coronary intervention (PCI) to treat calcified lesions.
The trial is the first prospective all-female study of PCI in complex calcific disease and aims to confirm the benefits of coronary intravascular lithotripsy in a real-world, female patient population.
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The EMPOWER CAD study has enrolled 400 subjects across 48 centres in five countries.
Shockwave Medical announced it had finished enrolling patients during a live case at this year’s annual Transcatheter Cardiovascular Therapeutics Conference in Washington DC.
Shockwave Medical chief medical officer Nick West said: “We are proud of, and grateful to, all of the dedicated investigators who enrolled on this study well ahead of all our expectations, showcasing their commitment to the important issue of women’s cardiovascular care.
“This study is a critical step toward closing the gender gap in heart disease treatment, and we recognise the urgent need for clinical data that reflect the unique challenges that women with cardiovascular disease face.”
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By GlobalDataThe underrepresentation of women in cardiovascular clinical trials has been a persistent issue, with only around one-quarter of enrolled subjects being female and even fewer serving on trial leadership committees.
This disparity has resulted in a scarcity of gender-specific data, despite the higher risk of procedural complications that women face when undergoing PCI.
In an effort to increase diversity and leadership in clinical research, around 71% of the EMPOWER CAD trial’s enrolling sites were led by female principal investigators.
The study’s European lead is Nieves Gonzalo, a consultant interventional cardiologist at the Hospital Clinico San Carlos in Madrid, Spain.
Primary endpoint results from the EMPOWER CAD study are expected to be presented next year, with patients being followed for up to three years thereafter.
