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Updated: Oct 2, 2025

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Interim outcomes of mechanical thrombectomy for deep vein thrombosis from the All-Comer CLOUT Registry

David J Dexter1, Herman Kado2, Jonathan Schor3

  • 1Sentara Vascular Specialists, Norfolk, VA.

Journal of Vascular Surgery. Venous and Lymphatic Disorders
|February 26, 2022
PubMed

Insights

The ClotTriever System effectively removed thrombus in 86% of patients with lower extremity deep vein thrombosis (DVT). This all-comer study showed sustained clinical improvements and a favorable safety profile at six months.

Area of Science:

  • Vascular Surgery
  • Interventional Radiology
  • Medical Device Technology

Background:

  • Deep vein thrombosis (DVT) affects a significant patient population, with varying chronicity and treatment challenges.
  • Current treatment options for DVT may have limitations, particularly in "all-comer" patient groups.
  • The ClotTriever System offers a minimally invasive approach for mechanical thrombectomy.

Purpose of the Study:

  • To assess the safety and effectiveness of the ClotTriever System in an all-comer population with lower extremity DVT.
  • To evaluate thrombus removal rates, safety outcomes, and long-term clinical improvements.
  • To analyze outcomes across a spectrum of thrombus chronicity.

Main Methods:

  • Prospective, single-arm CLOUT registry study of 250 patients with lower extremity DVT.
  • Inclusion of diverse patient profiles, including those with bilateral DVT, failed prior treatments, and varied symptom durations.
  • Primary endpoint: complete or near-complete thrombus removal (≥75%) assessed by Marder scores; secondary endpoints: safety events and clinical outcomes (post-thrombotic syndrome, pain, quality of life) at 6 months.

Main Results:

  • High effectiveness: 86% of limbs achieved complete or near-complete thrombus removal.
  • Favorable safety: Only one device-related serious adverse event reported within 30 days.
  • Significant clinical improvements: Sustained reductions in post-thrombotic syndrome (24% at 6 months), pain, and improved quality of life.
  • Efficient procedure: Median thrombectomy time of 28 minutes, with 99.6% treated in a single session, and no patients requiring thrombolytics.

Conclusions:

  • The CLOUT registry demonstrates the ClotTriever System's favorable safety and effectiveness in an all-comer DVT population.
  • The system achieves high rates of thrombus removal across acute, subacute, and chronic DVT.
  • Sustained clinical benefits and improvements in quality of life are observed at six months post-treatment.
Abstract

Keywords:
Deep vein thrombosisMechanical thrombectomyPost-thrombotic syndrome

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