Clinical trial NCT03575364: ClotTriever Outcomes (CLOUT) Registry
Official title: ClotTriever Outcomes (CLOUT) Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Deep Vein Thrombosis Leg
DVT
Chronic DVT of Lower Extremity
Acute DVT of Lower Extremity
Keywords: ClotTriever
Thrombectomy
Lead sponsor: Inari Medical
Sponsor class: INDUSTRY
First posted: 2018-07-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with proximal lower extremity DVT.

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


Eligibility criteria: 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

Primary outcomes:
measure: Composite of Major Adverse Events (MAEs)
timeFrame: 30 days
Secondary outcomes:
measure: Technical Success
timeFrame: Index procedure
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: St. Vincent's East
state: Alabama
city: Birmingham
country: United States
facility: Affinity Cardiovascular Specialists
state: Alabama
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Orange
country: United States
facility: Vascular and Interventional Specialists of Orange County
state: California
city: Denver
country: United States
facility: University of Colorado, Denver
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Washington
country: United States
facility: MedStar Health Research Institution
state: District of Columbia
city: Bradenton
country: United States
facility: Manatee Memorial Hospital
state: Florida
city: Jacksonville
country: United States
facility: Memorial Hospital Jacksonville
state: Florida
city: Lakeland
country: United States
facility: Lakeland Vascular Institute
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center of Florida
state: Florida
city: Tampa
country: United States
facility: AdventHealth Tampa
state: Florida
city: Gainesville
country: United States
facility: Longstreet Clinic
state: Georgia
city: Wichita
country: United States
facility: Wesley Medical Center
state: Kansas
city: Louisville
country: United States
facility: Surgical Care Associates
state: Kentucky
city: Lafayette
country: United States
facility: Lafayette General
state: Louisiana
city: Opelousas
country: United States
facility: Opelousas General
state: Louisiana
city: Bay City
country: United States
facility: McLaren Bay Heart and Vascular
state: Michigan
city: Farmington Hills
country: United States
facility: Millenium Cardiology
state: Michigan
city: Grand Blanc
country: United States
facility: Ascension Genesys Hospital
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Health
state: Michigan
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Lee's Summit
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Washington University at St. Louis
state: Missouri
city: Hackensack
country: United States
facility: Hackensack Meridian
state: New Jersey
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Buffalo
country: United States
facility: SUNY, The University at Buffalo
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Staten Island
country: United States
facility: Northwell Health
state: New York
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Fairfield
country: United States
facility: Mercy Health - The Heart Institute
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Heart Institute
state: Oklahoma
city: Philadelphia
country: United States
facility: Thomas Jefferson
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network Research Institute
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health - Upstate
state: South Carolina
city: Germantown
country: United States
facility: Methodist Healthcare Foundation
state: Tennessee
city: Houston
country: United States
facility: Houston Healthcare Medical Center
state: Texas
city: Houston
country: United States
facility: University of Texas Health Sciences Center - Houston
state: Texas
city: Norfolk
country: United States
facility: Sentara Vascular Specialists
state: Virginia
city: Spokane
country: United States
facility: Providence Sacred Heart
state: Washington
city: La Crosse
country: United States
facility: Gunderson Health
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
Study officials:
References: