RevCore for In Stent Thrombosis

Launched by INARI MEDICAL · Apr 30, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the RevCore Thrombectomy Catheter, a device designed to treat blockages in stents, which are small mesh tubes placed in veins to keep them open. The goal of the study is to gather information on how well this catheter works for patients who have developed a blockage in their stents after having them for more than six weeks.

To participate in the trial, candidates must be at least 18 years old and have a blockage in specific veins in the leg. However, there are certain conditions that would exclude someone from joining, such as having damaged stents or other serious health issues that could complicate treatment. If eligible, participants can expect to have the procedure done using the RevCore catheter, and the study will monitor their progress. It's important for potential participants to be willing to provide consent and understand that their health will be closely watched throughout the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years
• • 2. Patients with stent age \> 6 weeks
• • 3. Location of thrombosed stents in proximal lower extremity deep vein segments including at least common femoral, external iliac, or common iliac vein
• • 4. RevCore Thrombectomy Catheter must enter vasculature
• • 5. Willing and able to provide informed consent
• Exclusion Criteria:
• • 1. Exposed stents with broken struts, significantly deformed struts, struts protruding into the vessel
• • 2. Stents not wall apposed
• • 3. Stents compressed to \<10mm
• • 4. Bilateral in-stent thrombosis
• • 5. Congenital anatomic anomalies of the iliac veins
• • 6. Allergy, hypersensitivity, or thrombocytopenia from heparin or iodinated contrast agents, except for mild to moderate contrast allergies for which pretreatment can be used
• • 7. Any contraindication to anticoagulants or antiplatelets that, in the opinion of the Investigator, cannot be medically managed throughout the study period
• • 8. Chronic non-ambulatory status
• • 9. Known hypercoagulable states (e.g. antiphospholipid syndrome) that, in the opinion of the Investigator, cannot be medically managed throughout the study period
• • 10. Inability to secure venous access
• • 11. Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject
• • 12. Current participation in another investigational drug or device treatment study