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CLOUT Registry

The largest prospective mechanical thrombectomy study in the field of deep vein thrombosis (DVT).


NCT03575364

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CLOUT | Stryker

Design

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Objective

  • Evaluate real-world patient outcomes after treatment of acute, subacute, and chronic proximal lower extremity DVT with the ClotTriever system








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Design

  • Prospective multicenter, all-comer registry of 500 patients enrolled at 43 US sites
  • Study conduct: independent core laboratory 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
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Primary Effectiveness Endpoint

  • Complete or near-complete (≥75%) removal of thrombus from the target venous segments via venographic Marder score









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Key Eligibility Criteria

  • Inclusion:
    • Patients enrolled irrespective of symptom duration
    • Age ≥ 18 years
    • Unilateral or bilateral proximal lower extremity DVT
  • Exclusion:
    • Patients with IVC filter present at time of DVT treatment or prior stenting of the target vessel segment were excluded
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Duration of Patient Follow-up

  • Patients were 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)

Established safety outcomes

Device-related serious adverse events (SAEs)
(n=499)

Vessel damage, valve damage, acute kidney injury
(n=499)

Rethrombosis/residual thrombus SAE rate (30 days)
(n=499)

  

Sustained improvements in
PTS symptoms at 2 years

No PTS or mild PTS symptoms
(n=265)

Clinical evidence

2025 ESVM: New DVT guidelines state for endovascular treatment of acute DVT, the use of catheter-based mechanical thrombectomy should be preferred over CDT or USAT.

See 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