The objective of this study is to demonstrate the safety and efficacy of the Indigo Aspiration system for percutaneous mechanical thrombectomy in a population presenting with obstruction due to deep vein thrombosis (DVT) who are eligible for treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
229
Indigo Aspiration System
Composite of Major Adverse Events
Device related death, major bleeding, new symptomatic pulmonary embolism or re-thrombosis of the target venous segment and serious device related events
Time frame: 48 Hours Post-Procedure
Change in Marder Score
Complete or near complete (75% or greater) reduction of venous thrombus from the target venous segment as measured by Marder Score pre- to post-procedure The Marder Score ranges from 0 to 24, with higher scores being worse.
Time frame: Index Procedure
Composite of Major Adverse Events
A composite of death, major bleeding, new symptomatic pulmonary embolism or re-thrombus of the target venous segment
Time frame: 30 Days Post-Procedure
Device Related Adverse Events
Proportion of participants with device related adverse events
Time frame: 24 Months
Villalta Scale
Villalta scores reported at baseline, 30 days, 180 days, 12 months, and 24 months Villalta score ranges from 0 (no post thrombotic syndrome) to 33 (severe post thrombotic syndrome), with higher scores being worse.
Time frame: 24 Months
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