This study is a prospective, multicenter, randomized controlled trial of an interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm) versus conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm) in the treatment of subjects with symptomatic unilateral iliofemoral DVT. The study will collect data on demographics, comorbidities, details from the DVT diagnosis and treatment, and clinical outcomes through the 6-month follow up visit.
The study will compare the clinical outcomes of patients treated with an interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm) versus conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm) in the treatment of symptomatic unilateral iliofemoral DVT. Approximately 300 subjects will be enrolled and randomized. All subjects who sign informed consent and who meet all of the inclusion criteria and none of the exclusion criteria will be randomized (1:1, ClotTriever Intervention Arm or Conservative Medical Management Arm).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Mechanical thrombectomy
Anticoagulants are a group of medications that decrease your blood's ability to clot.
Honor Health
Scottsdale, Arizona, United States
RECRUITINGPima Heart and Vascular
Tucson, Arizona, United States
RECRUITINGUCI Medical Center
Orange, California, United States
RECRUITINGVascular and Interventional Specialists of Orange County
Orange, California, United States
Composite clinical endpoint constructed as a win ratio, a hierarchy of the following:
1. Occurrence of treatment failure or therapy escalation 2. Assessment of PTS severity, as defined by the Villalta scale
Time frame: 180 Days (+-14 Days)
Composite clinical endpoint constructed as a win ratio, a hierarchy of the following:
1. Vessel compressibility assessed by duplex ultrasound 2. Pain as assessed by the NPRS 3. An improvement of edema as assessed by leg calf circumference measurements
Time frame: 10 Days (+- 3 Days)
Assessment of PTS Severity:
a. Assessment of PTS severity, as defined by the Villalta scale
Time frame: 180 Days (+-14 Days)
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Huntington Health
Pasadena, California, United States
RECRUITINGUniversity Of Colorado
Denver, Colorado, United States
RECRUITINGYale University
New Haven, Connecticut, United States
RECRUITINGMedStar Health Research Institution
Washington D.C., District of Columbia, United States
RECRUITINGManatee Memorial Hospital
Bradenton, Florida, United States
TERMINATEDBaptist Health Research Institute
Jacksonville, Florida, United States
RECRUITING...and 54 more locations