ClotTriever Outcomes (CLOUT) Registry



Status:Enrolling by invitation
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 75
Updated:7/20/2018
Start Date:August 1, 2018
End Date:August 1, 2022

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Evaluate real world patient outcomes after treatment of acute and non-acute lower extremity
deep vein thrombosis (DVT) with the ClotTriever Thrombectomy System.


Inclusion Criteria:

- Lower extremity DVT involving the femoral, common femoral, iliac veins or inferior
vena cava (IVC), alone or in combination.

Exclusion Criteria:

- Prior venous stent in the target venous segment

- Poor inflow to the treated segments

- IVC aplasia/hypoplasia or other congenital anatomic anomalies of the IVC or iliac
veins

- Diagnosed or suspected PE with hemodynamic instability any time within 3 months of the
planned index procedure

- PE signs or symptoms within 3 months of the planned index procedure without CTPA
assessment performed within 7 days of the planned index procedure

- Allergy, hypersensitivity, or thrombocytopenia from heparin or iodinated contrast
agents, except for mild to moderate contrast allergies for which pretreatment can be
used

- Life expectancy less than 1 year

- Chronic non-ambulatory status

- Known hypercoagulable states that, in the opinion of the Investigator, cannot be
medically-managed throughout the study period

- Unavailability of a lower extremity venous access site
We found this trial at
2
sites
Chapel Hill, North Carolina 27599
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Chapel Hill, NC
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Miami Beach, Florida 33140
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Miami Beach, FL
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