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 Months90.1%
Normal flow via duplex ultrasound100%
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.