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Important Notice
This Inari Medical website and all product offerings listed are tailored for the United States only. Please be aware that product availability and regulatory claims may vary in other regions we serve, including Europe, the Middle East, and Africa (EMEA), Asia-Pacific (APAC), and Latin America/Canada. Inari Medical is currently developing separate websites for our products tailored to these other global and regional markets.
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Randomized controlled trial (RCT)
of ClotTriever® vs. anticoagulation alone
in deep vein thrombosis (DVT)
DEFIANCE RCT
NCT05701917
300 Patients Randomized 1:1
  • Prospective, multicenter, randomized controlled trial of ClotTriever thrombectomy versus anticoagulation alone in symptomatic unilateral iliofemoral DVT
  • 300 patients (1:1 ClotTriever vs. anticoagulation alone) at up to 60 sites
  • Study Conduct:
  • Independent core laboratory for duplex ultrasound
  • Independent medical monitor for safety adjudication
  • Best clinical practices1 to evaluate PTS severity, including Villalta assessment
Primary Endpoint
Win ratio composite
  1. Occurrence of treatment failure or therapy escalation
  2. Assessment of PTS severity, as defined by the Villalta scale, at the 6-month visit
Follow-Up
  • Patients are assessed at 10-day visit, 30-day visit, and 6-month visit
Eligible Patients:
Symptomatic unilateral iliofemoral DVT
300 Patients Randomized 1:1
ClotTriever Intervention Arm
Conservative Medical Management
(Anticoagulation) Arm
Randomization (+/- Index Procedure) > 10-Day Visit > 30-Day Visit > 6-Month Visit
References:
1. Kahn SR, et al. Definition of post-thrombotic syndrome of the leg for use in clinical investigations: a recommendation for standardization. J Thromb Haemost. 2009;7(5):879-83.

Indications for Use:
The ClotTriever® thrombectomy system is indicated for (1) the non-surgical removal of thrombi and emboli from blood vessels and (2) injection, infusion and/or aspiration of contrast media and other fluids into or from a blood vessel. The ClotTriever thrombectomy system is intended for use in the peripheral, vasculature, including deep vein thrombosis (DVT).

Refer to IFU for complete Indications for Use, contraindications, warnings, and precautions.

Caution:
Federal (USA) law restricts this device to sale by or on the order of a physician.

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