Decorative Graphic
Important Notice
This Inari Medical website and all product offerings listed are tailored for the United States only. Please be aware that product availability and regulatory claims may vary in other regions we serve, including Europe, the Middle East, and Africa (EMEA), Asia-Pacific (APAC), and Latin America/Canada. Inari Medical is currently developing separate websites for our products tailored to these other global and regional markets.
Decorative Graphic
Standout Performance.
Unmatched Outcomes.
CLOUT Registry
NCT03575364
The largest prospective mechanical thrombectomy study in the field of deep vein thrombosis (DVT)
Jump to outcomes
Objective Graphic
Objective
  • Evaluate real-world patient outcomes after treatment of acute, subacute, and chronic proximal lower extremity DVT with the ClotTriever system
Objective Graphic
Design
  • Prospective multicenter, all-comer registry in 500 patients enrolled at 43 US sites
  • Study conduct: independent core lab to assess primary effectiveness endpoint and an independent medical monitor to assess safety events
  • Variables Collected:
  • Procedural Data
  • Safety: Total and device-related SAEs
  • Other Outcomes: Duplex US, Post-thrombotic Syndrome (PTS) assessment via Villalta score, rVCSS, NPRS, EQ-5D
Objective Graphic
Primary Effectiveness Endpoint
  • Complete or near complete (≥75%) removal of thrombus from the target venous segments via venographic Marder score
Objective Graphic
Key Eligibility Criteria
  • Inclusion:
    • Age ≥ 18
    • Unilateral or bilateral proximal lower extremity DVT
    • Patients enrolled irrespective of symptom duration
  • Exclusion:
    • Patients with IVC filter present at time of DVT treatment or prior stenting of the target vessel segment were excluded
Objective Graphic
Duration of Patient Follow-up
  • Patients are assessed at
    • discharge
    • 30-day visit
    • 6-month visit
    • 1-year visit
    • 2-year visit
CLOUT Outcomes1, 2, 3
Significant clot removal
in a single session
>90%
Complete or
near-complete
thrombus removal*
(n=486)
40ml
Median estimated
blood loss
(n=448)
99.4%
Single session
treatment
(n=499)
Excellent safety outcomes
0.2%
Device-related serious
adverse events (SAEs)
(n=499)
0
Vessel damage, valve
damage, acute
kidney injury
(n=499)
5.0%
Rethrombosis/residual
thrombus SAE rate (30 days)
(n=499)
Sustained improvements in
PTS symptoms at 2 years
93%
none or mild PTS symptoms
(n=206)
Read the Peer-Reviewed
CLOUT Results
One-Year Clinical
Outcomes: A CLOUT
Registry Analysis
See Results
Outcomes from the
ClotTriever Registry
show symptom duration
may underestimate
DVT chronicity
See Results
6-Month DVT Outcomes
by Chronicity: Analysis of
the Real-World ClotTriever
Outcomes Registry
See Results
CLOUT vs. ATTRACT
AC PSM
See Results
6-Month Outcomes
of Mechanical
Thrombectomy for
Treating DVT: Analysis
from the 500-Patient
CLOUT Registry
See Results
Safety and Effectiveness
of Mechanical
Thrombectomy from
the Fully Enrolled
CLOUT Registry
See Results
Association Between
30-Day Villalta Scores and
Long-Term PTS Incidence
and Severity Following
Acute DVT
See Results
Mechanical Thrombectomy
vs. Pharmacomechanical
CDT for the Treatment of
Iliofemoral DVT: A Propensity
Score Matched Exploratory
Analysis of 12 Month
Clinical Outcomes
See Results
* ≥75% thrombus removal assessed via Marder score by an independent core laboratory

References:
1. Dexter D, et al. Safety and effectiveness of mechanical thrombectomy from the fully enrolled multicenter, prospective CLOUT registry. J Soc Cardiov Angiog Interv. 2023;2(2):100585.
2. Shaikh A, et al. Six-month outcomes of mechanical thrombectomy for treating deep vein thrombosis: analysis from the 500-patient CLOUT registry. Cardiovasc Intervent Radiol. 2023; 46(11):1571-1580.
3. Dexter, D. Interim two year outcomes from the fully enrolled CLOUT registry. Presented at AVF 2024 (Tampa, FL).

Indications for Use:
The ClotTriever® thrombectomy system is indicated for (1) the non-surgical removal of thrombi and emboli from blood vessels and (2) injection, infusion and/or aspiration of contrast media and other fluids into or from a blood vessel. The ClotTriever thrombectomy system is intended for use in the peripheral, vasculature, including deep vein thrombosis (DVT).

Refer to IFU for complete Indications for Use, contraindications, warnings, and precautions.

Caution:
Federal (USA) law restricts this device to sale by or on the order of a physician.

All trademarks are property of their respective owners.