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Published on: November 26, 2013
Safety and Effectiveness of Mechanical Thrombectomy From the Fully Enrolled Multicenter, Prospective CLOUT Registry
David Dexter1, Herman Kado2,3, Abdullah Shaikh4
1Sentara Vascular Specialists, Norfolk, Virginia.
Insights
Mechanical thrombectomy using the ClotTriever System effectively treats deep vein thrombosis (DVT) in the legs, showing high success rates and minimal complications. This minimally invasive procedure offers significant patient improvement without intensive care needs.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Medical Devices
Background:
- Proximal lower extremity deep vein thrombosis (DVT) poses significant health risks.
- Percutaneous mechanical thrombectomy is an evolving treatment modality for DVT.
- The ClotTriever System offers a novel approach to mechanical thrombectomy.
Purpose of the Study:
- To evaluate the in-hospital outcomes of the ClotTriever System in patients with proximal lower extremity DVT.
- To assess the safety and effectiveness of mechanical thrombectomy for DVT.
- To analyze patient health status improvements post-treatment.
Main Methods:
- Prospective, single-arm, multicenter CLOUT registry.
- Enrollment of up to 500 patients with proximal lower extremity DVT.
- Assessment of primary effectiveness endpoint (≥75% Marder score reduction) by an independent core laboratory.
- Adjudication of mortality and serious adverse events by an independent medical monitor.
Main Results:
- High procedural success: 91.2% of limbs achieved primary effectiveness endpoint.
- Excellent safety profile: 0.2% device-related serious adverse event.
- Minimal invasiveness: 99.4% single-session procedures, negligible blood loss, and 97.8% avoided ICU monitoring.
- Significant improvements in patient health status, including reduced pain and limb edema.
Conclusions:
- The ClotTriever System is a safe and effective treatment for proximal lower extremity DVT.
- Mechanical thrombectomy with ClotTriever avoids the need for intensive care unit monitoring.
- Early improvements in patient health status were observed, with long-term follow-up ongoing.
Background:
We report in-hospital outcomes from the multicenter, prospective, single-arm ClotTriever Outcomes (CLOUT) registry, which enrolled up to 500 patients with proximal lower extremity deep vein thrombosis (DVT) treated with percutaneous mechanical thrombectomy using the ClotTriever System (Inari Medical).
Methods:
The CLOUT registry enrolled all-comer patients with DVT, irrespective of symptom duration, thrombus age, prior treatment of the current DVT, or bilateral thrombus. The primary effectiveness end point was defined as complete or near complete (≥75%) reduction in Marder score. Thrombus burden was assessed by an independent core laboratory. Mortality and serious adverse events, including device-relatedness, were adjudicated by an independent medical monitor. Here, safety and outcomes are evaluated through discharge.
Results:
The median age was 61.9 years (IQR, 48.0-70.8), 50.5% were women, 24.9% had a history of DVT, and 23.2% had previously failed treatment of the current DVT. Nearly all procedures (99.4%) were performed in a single session with negligible procedural blood loss (median 40.0 mL; IQR, 20.0-50.0), and most patients (97.8%) required no subsequent intensive care unit monitoring. The primary effectiveness end point was achieved in 91.2% of limbs. Through discharge, 1 device-related serious adverse event (0.2%) occurred. Health status, as assessed by self-reported pain and circumferential measurements of limb edema, were significantly improved at discharge.
Conclusions:
Thrombectomy with the ClotTriever System is a safe and effective treatment for proximal lower extremity DVT, while also avoiding the need of intensive care. Early patient improvements are demonstrated, and follow-up is ongoing to 2 years.
