AVF 2023: One-year analysis of CLOUT registry reveals “significant and sustained” long-term clinical improvements

David Dexter presents at AVF 2023

Interim one-year outcomes from the multicentre, prospective, single-arm CLOUT registry investigating use of the ClotTriever thrombectomy system (Inari Medical) in all-comer patients with deep vein thrombosis (DVT) demonstrated that 93.5% of limbs had flow present, 97.1% were compressible and 10.5% of patients presented with moderate or severe post-thrombotic syndrome (PTS).

The results were presented by David Dexter (Eastern Virginia Medical School, Norfolk, USA) at the 2023 annual meeting of the American Venous Forum (AVF; 22–25 February, San Antonio, Texas).

Dexter reported that 12-month follow-up among 176 patients was completed, with 20% presenting with a PTS Villalta score of greater than 4—and 17 limbs, or 10.5%, with a score greater than 9 (moderate or severe).

The primary effectiveness endpoint—complete or near-complete (≥75%) clot removal, assessed by an independent core laboratory—was achieved in 91.2% of patients. Nearly two-thirds of patients saw complete thrombus removal. “Patients reported immediate symptom relief and demonstrated sustained improvements in one-year clinical and quality-of-life outcomes,” Dexter told AVF 2023. Rates of PTS “remained low” at the one-year mark, he added.

Dexter concluded: “This one-year interim analysis from the real-world CLOUT registry indicates that the ClotTriever system can effectively remove thrombi with significant and sustained long-term clinical improvements, including PTS, pain, and quality of life. Follow-up with the complete dataset to two years is ongoing.”


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