Assess the safety and effectiveness of the ClotTriever System in the treatment of acute and chronic lower extremity Venous clot.
- Prospective, single-arm, multicenter registry
- 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 comers, excluding patients with IVC filter or stent
- 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
Initial Readout of CLOUT Registry’s First 50 Patients at 2019 VIVA Conference
76.5% Complete or Near Complete Clot Removal
75.8% Complete Reversal of PTS Within 30 Days
Key Procedural Information2
Presented with Clot Older than 2 Weeks
Average ClotTriever Device Time
Previously Treated for DVT within 30 Days Prior
Estimated Blood Loss
Treated in a Single Session
Median Hospital Stay
Patients experienced acute improvements in disease severity and quality of life at 30-day follow-up with no device or procedure related major adverse events. Initial CLOUT data demonstrates the ability of ClotTriever to successfully treat a range of clot chronicity in real world DVT patients in a single session, without the need for thrombolytic drugs.
(1)These initial results included procedural outcomes and information from these patients and outcomes from 33 patients for which follow-up data was collected 30 days after treatment.
(2)Represents median (interquartile range) or n (%).