Design
300 Patients Randomized 1:1
- Prospective, multicenter, randomized controlled trial of ClotTriever thrombectomy versus anticoagulation alone in symptomatic unilateral iliofemoral DVT
- 300 adults (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 practices2 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
DEFIANCE
Eligible patients:
Symptomatic unilateral iliofemoral DVT
Symptomatic unilateral iliofemoral DVT
Randomization (+/- Index Procedure) > 10-Day Visit > 30-Day Visit > 6-Month Visit
References
- Abramowitz SD, et al. Rationale and design of the DEFIANCE study: A randomized controlled trial of mechanical thrombectomy versus anticoagulation alone for iliofemoral deep vein thrombosis. Am Heart J. 2025;281:92-102.
- 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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PRO-4513-USA-EN-v1