Inari’s ClotTriever Outcomes Evaluated at 30 Days in Fully Enrolled CLOUT Registry

November 2, 2022—David Dexter, MD, presented in-hospital and 30-day outcomes from the fully enrolled, multicenter, prospective CLOUT registry. The CLOUT (ClotTriever Outcomes) registry is an all-comer, multicenter study evaluating patient outcomes following treatment of proximal, lower extremity deep vein thrombosis (DVT) with the ClotTriever system (Inari Medical).

Dr. Dexter presented the findings in a Late-Breaking Clinical Trials session at The VEINS conference, hosted by the VIVA Foundation and held October 30-31, 2022, in Las Vegas, Nevada.

According to the VIVA Foundation press release, this analysis from the now fully enrolled registry represents the largest mechanical thrombectomy study in the field of DVT. All-comer patients were enrolled—irrespective of symptom duration, thrombus age, previously failed treatment of the current DVT, or bilateral disease—providing a generalizable patient population.

The primary endpoint was complete or near-complete (≥ 75%) thrombus removal, assessed by an independent core laboratory. Serious adverse events (SAEs), including device-relatedness, were evaluated at 30 days by an independent medical monitor.

Results were presented through 30-day follow-up.

As summarized by the VIVA Foundation, the primary endpoint was achieved in 91.2% of limbs, and the 30-day device-related SAE rate was 0.2%. Also, 99.4% of procedures were single sessions, median estimated blood loss was low at 40.0 mL, and 2.2% of patients received overnight postthrombectomy intensive care unit monitoring.

Patient symptoms (eg, pain and edema) were significantly reduced at discharge and showed sustained improvement through 30 days.

Further significant 30-day outcomes include recovery of vessel flow and compressibility as measured by duplex ultrasound, improvements in revised Venous Clinical Severity Score and EuroQoL five-dimension quality-of-life score, median 5.5-point reduction in Villalta score, and < 10% of patients with a moderate or severe Villalta score (≥ 10).

The investigator concluded that the analysis of the CLOUT registry shows the excellent safety profile and effective thrombus removal of mechanical thrombectomy with the ClotTriever system in a real-world DVT patient population, reported the VIVA Foundation.