ClotTriever Outcomes (CLOUT) Registry

Inari Medical

Status: Completed

Conditions: Acute DVT of Lower Extremity; Chronic DVT of Lower Extremity; Deep Vein Thrombosis Leg; DVT

Treatments: Device: ClotTriever

Study type: Observational

Funder types: Industry

Identifiers

NCT03575364

18-001

Details and patient eligibility

About

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

Full description

The CLOUT Registry is a prospective, multi-center, observational registry of subjects with proximal lower extremity DVT treated with the ClotTriever Thrombectomy System. The Registry will collect data on demographics, comorbidities, details from the DVT diagnosis and treatment, and clinical outcomes through 2 years of follow-up.

Enrollment: 499 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Proximal lower extremity DVT involving the femoral, common femoral, iliac veins, or inferior vena cava (IVC), alone or in combination.
• Willing and able to provide informed consent.

Exclusion criteria

• Prior venous stent in the target venous segment
• IVC aplasia/hypoplasia or other congenital anatomic anomalies of the IVC or iliac veins
• IVC filter in place at the time 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

Trial design

499 participants in 2 patient groups

Primary Analysis Population

Description:

Patients with unilateral acute or subacute DVT of less than or equal to 6 weeks' duration without recent (≤ 3 month) history of venous intervention.

Treatment:

Device: ClotTriever

Full Analysis Population

Description:

Subjects with proximal lower extremity DVT involving the femoral, common, femoral, iliac veins or inferior vena cava (IVC), alone or in combination.

Treatment:

Device: ClotTriever