Objective
Assess the safety and effectiveness of the ClotTriever System in the treatment of acute and chronic lower extremity Venous clot.
Design
- Assess the safety and effectiveness of the ClotTriever System in the treatment of acute and chronic lower extremity Venous clot.
Key Inclusion Criteria
- Age ≥ 18 all comers, excluding patients with IVC filter or stent
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)
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 Highlights
CLOUT Interim Analysis 250 Patient, 6-Month Follow-Up Data
Presented at NCVH June 2021
THE PURSUIT OF
LYTIC-FREE, SINGLE-SESSION, BLOODLESS THROMBECTOMY
99.6%
Single Session Treatment
50.0mL
Median Estimated Blood Loss
0mg
Thrombolytics Used
100%
Clot removal in the majority of patients
via core lab-adjudicated Marder scores
DEMONSTRATED SAFETY
30-Day Safety Outcomes
Vessel / Valve Damage
0.0%
Acute Renal Injury
0.0%
Device Related SAEs
0.4%
Vessel / Valve Damage
Acute Renal Injury
Device Related SAEs
0.0%
0.0%
0.4%
LIFE WITHOUT CLOT
6 Month Outcomes
Normal flow via duplex ultrasound
89.7%
Freedom from moderate or severe PTS
92.2%
Reduction in pain
(NPRS median score)
100%
89.7%
92.2%
100%
Normal flow via duplex ultrasound
Freedom from moderate or severe PTS
Reduction in pain
(NPRS median score)
Conclusions
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.
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