Rapid Medical has announced the completion of patient enrolment in the DISTALS trial—a multicentre randomised study assessing the Tigertriever 13 device in patients with distal/medium-vessel occlusions (DMVOs) in acute ischaemic stroke.
“DMVO strokes represent up to 40% of ischaemic strokes and can cause significant disability, yet their treatment has remained uncertain,” said DISTALS principal investigator Jeffrey Saver (University of California Los Angeles [UCLA], Los Angeles, USA). “Recent neutral results from ESCAPE-MeVO and DISTAL made one thing clear: distal thrombectomy requires devices and trials specifically engineered for distal vessels. Tiger 13 and DISTALS bring that dedicated design. Completing enrolment is a major step toward evidence that can truly advance care for these patients.”
According to Rapid, the Tiger 13 is purpose-built for distal interventions, and its proprietary, adjustable design makes it “the only thrombectomy device that can actively remove tension from the vessel during clot retrieval”, allowing physicians to minimise shear forces on delicate distal arteries. A previously announced interim safety analysis of DISTALS reported no safety concerns, supporting Tiger 13’s use in fragile distal territories, the company also notes in a recent press release.
“Tiger 13 is the only device I trust for distal stroke thrombectomy,” commented DISTALS principal investigator Rishi Gupta (Wellstar Health System, Marietta, USA). “Its design meets the real-world demands of small, highly tortuous distal vessels. We cannot rely on devices built for proximal occlusions to solve a distal problem—dedicated engineering is essential, and Tiger 13 delivers it.”
Completion of enrolment in DISTALS marks a significant milestone toward generating the high-quality clinical data needed to guide the next evolution of stroke treatment, Rapid’s release states.
The trial is also being led by principal investigators René Chapot (Alfried Krupp Krankenhaus, Essen, Germany) and David Fiorella (Stony Brook University Medical Center, Stony Brook, USA).
