Objective

Evaluate real world patient outcomes after treatment of acute, subacute, and chronic proximal lower extremity DVT with the ClotTriever System

Design

  • Prospective multi-center, all-comer registry

Primary Objectives

  • Technical success: complete or near-complete (≥75% removal of thrombus from the treated vein segments via Marder score with venography)
  • Composite MAE at 30 days: all-cause mortality, major bleeding, PE, re-thrombosis of treated vein segment(s)

Key Inclusion Criteria

  • Age ≥ 18 all-comer, excluding patients with IVC filter or stent

Study Size

  • Up to 500 patients total
  • Primary Analytic Arm: 91 pts with unilateral acute and chronic DVT (clot age ≤ 6 weeks) followed 30 days
  • Registry Arm: Up to 409 patients followed 2 yrs. All comer arm including patients with bilateral disease and clot age ≥ 6 weeks

CLOUT Registry Interim Results (N=250)

ClotTriever System Outcomes in Lower Extremity DVT, including Sub-Analysis by Thrombus Chronicity

Lytic-free Mechanical Thrombectomy

Procedural Results

Significant Thrombus Removal Across DVT Chronicity

*≥75% thrombus removal determined by independent core laboratory-adjudicated Marder scores

Positive Safety Outcomes

At 30 Days*

Vessel / Valve Damage

0.0 %

Acute Renal Injury

0.0%

Device Related SAEs

0.4%

*Adjudicated by an independent medical monitor

Long-Term Patient Benefits

At 6 Months

90.1%

Normal flow via duplex ultrasound

100%

Median reduction in pain

Conclusions

Positive 6-month results of the first 250 patients enrolled in the multi-center, prospective, all-comer CLOUT registry show successful thrombus removal was achieved in 85.8% of patients in a single session without the use of thrombolytics. Effective thrombus removal led to significant improvements in duplex ultrasound assessments and clinical outcomes through 6 months for all DVT chronicity subgroups.