Concept Medical has shared the latest update from its IMPRESSION (Sirolimus-coated balloon angioplasty versus plain balloon angioplasty in the treatment of dialysis access dysfunction) randomised controlled trial (RCT), as it crosses the 50% enrolment mark.
The IMPRESSION trial enrolled its index patient on 11 January 2021 to assess the efficacy of the MagicTouch sirolimus-coated balloon (Concept Medical) against a placebo plain balloon in dysfunctional arteriovenous fistulas (AVFs). Since then, the prospective, multicentre, two-arm parallel group RCT has continued enrolling rapidly and has already crossed the 50% enrolment mark in just over 10 months.
The trial—under lead principal investigator (PI) Suai Chieh Tan, head and senior consultant, Department of Renal Medicine, Singapore General Hospital, Singapore, along with site PIs Edward Choke (Sengkang General Hospital, Singapore) and Jackie Ho Pei (National University Heart Centre, Singapore)—targets enrolment of 170 patients with end-stage kidney disease (ESKD) and a matured dysfunctional AVF across these three sites.
The primary aim of the trial is to evaluate primary circuit patency improvement at six months while comparing the MagicTouch AVF and placebo plain balloon in 1:1 randomised fashion.
According to a Concept Medical press release, the trial is doing “exceedingly well”, with 90 patients successfully enrolled so far. And, although the past year was shrouded by COVID-19, and impacted many healthcare institutions, the rate of enrolment has not slowed down.
“I would like to thank all the patients who have participated in the study. I hope that, together, we can find a better treatment to improve your health and many others who are experiencing the same recurring problem of a dysfunctional fistula,” said Tan.
Plain balloon angioplasty has historically been the “go-to” procedure in this area, the release adds. However, its long-term patency is poor, as ESKD patients often experience re-narrowing of their AVF or arteriovenous graft (AVG) due to stenosis. Paclitaxel-coated balloons are also being used to treat dysfunctional AVF—but mixed results have been coupled with safety concerns raised by the US Food and Drug Administration (FDA) regarding paclitaxel, Concept Medical claims.
The sirolimus-coated balloon thus “seems to be a promising option”, the release concludes, as the MagicTouch AVF was granted Breakthrough Device designation by the FDA in 2019, and the IMPRESSION RCT “will provide much-needed data” to reinforce this.