Objective:
Assess the safety and effectiveness of the ClotTriever System in the treatment of acute and chronic lower extremity Venous clot.
Design
- Prospective, single-arm, multicenter 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 comers, 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 Highlights
Initial Readout of CLOUT Registry’s First 50 Patients at 2019 VIVA Conference
Initial Results1
%
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
38 Mins
Average ClotTriever Device Time
%
Previously Treated for DVT within 30 Days Prior
27.5cc
Estimated Blood Loss
%
Treated in a Single Session
2 Days
Median Hospital Stay
Conclusions
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.
Source: Initial results from the first 50 patients in the CLOUT registry were presented at the Vascular InterVentional Advances, or VIVA, conference in November 2019.
(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 (%).
(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 (%).
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