Artix Thrombectomy System for Peripheral Arterial Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the Artix Thrombectomy System, a non-surgical treatment for removing blood clots in leg arteries. Researchers aim to determine if this system is safe and effective for individuals with sudden blockages in their leg arteries. Ideal participants have experienced symptoms for less than two weeks and have a diagnosed blockage below the hip. As an unphased trial, this study allows participants to contribute to groundbreaking research in non-surgical treatments for leg artery blockages.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you must be able to tolerate antiplatelet therapy and anticoagulation with heparin or similar medications.
What prior data suggests that the Artix Thrombectomy System is safe for patients with acute lower extremity arterial occlusions?
Research has shown that the Artix Thrombectomy System is generally safe for treating blocked arteries in the legs. Studies have found that this device can successfully restore blood flow without causing blood loss. In over 2,000 patients, results have been consistently positive.
However, one report noted a problem when the device got caught on an existing stent in a patient. This indicates that while the treatment is mostly well-tolerated, rare complications can occur, particularly in complex cases with existing medical devices. Despite this, the overall findings are promising, demonstrating the system's effectiveness and general safety for most patients.12345Why are researchers excited about this trial?
The Artix Thrombectomy System is unique because it offers a non-surgical way to remove clots from arteries in the lower extremities. Most treatments for peripheral arterial disease, like blood thinners or clot-dissolving medications, can take time to work, and surgical interventions are invasive. The Artix System, however, directly targets and removes the clots, potentially offering faster relief with less risk and recovery time than traditional surgery. Researchers are excited about this approach as it could provide a quicker, less invasive option for patients suffering from artery blockages.
What evidence suggests that the Artix Thrombectomy System is effective for peripheral arterial disease?
Studies have shown that the Artix Thrombectomy System, which participants in this trial will receive, effectively treats sudden blockages in leg arteries. In one study, doctors restored blood flow in all treated areas, achieving about 95% flow restoration. Another report showed a 100% success rate in restoring blood flow and saving limbs within 30 days. The system combines mechanical and suction methods to remove blood clots, enhancing its effectiveness. These findings suggest that the Artix Thrombectomy System reliably clears blockages in leg arteries.12345
Who Is on the Research Team?
Anahita Dua, MD
Principal Investigator
Massachusetts General Hospital
Shang Loh, MD
Principal Investigator
Penn Presbyterian Medical Center
Scott T Lewis
Principal Investigator
Inari Medical
Are You a Good Fit for This Trial?
This trial is for adults (18 or older) with a sudden blockage in an artery of the lower leg that started within the last 14 days. The blocked vessel must be between 3 and 8 mm wide, and symptoms should fit certain severity levels.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Non-surgical removal of lower extremity arterial emboli and thrombi using the Artix Thrombectomy System
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Artix Thrombectomy System
Trial Overview
The study is testing the Artix Thrombectomy System, a device used to remove blood clots from arteries in the legs. All participants receive this treatment to see how safe and effective it is.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Non-surgical removal of lower extremity arterial emboli and thrombi using the Artix Thrombectomy System.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Inari Medical
Lead Sponsor
Citations
Treatment of Acute Lower-Extremity Arterial Occlusions With a ...
By utilizing the Artix thrombectomy system, the treating physicians successfully revascularized all intended segments resulting in symptom ...
Artix™ Thrombectomy System and the Road Ahead
These data demonstrated high rates of technical success, including approximately 95% flow restoration and a median thrombus removal of about 95%. What stood out ...
Early Multicenter Experience With the Artix System for ...
Existing endovascular therapies for peripheral arterial occlusions have drawbacks associated with safety, procedural inefficiencies, and efficacy.
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evtoday.com
evtoday.com/articles/2025-nov/artix-redefining-arterial-thrombectomy-with-treatment-flexibility-and-controlArtix™: Redefining Arterial Thrombectomy With Treatment ...
Khanjan Nagarsheth reported highly encouraging outcomes with the Artix Thrombectomy System, achieving 100% flow restoration and a 100% limb salvage rate at 30 ...
The Artix™ Thrombectomy System: A Safe, Efficient, and ...
Physician insights highlight how Artix's dual thrombectomy approach—combining mechanical and aspiration—enhances thrombus removal efficiency, ...
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