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

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David Dexter presents at AVF 2023

Interim one-year outcomes from the multicenter, prospective, single-arm CLOUT registry investigating use of the ClotTriever thrombectomy system 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, MD, an assistant professor of surgery at Eastern Virginia Medical School in Norfolk, Virginia, at the 2023 annual meeting of the American Venous Forum (AVF) in San Antonio, Texas (Feb. 22–25).

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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