Using RevCore Catheter to Treat Stent Blockages

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research aims to gather data on the effectiveness of the RevCore Thrombectomy Catheter in treating in-stent thrombosis, which occurs when blood clots form within stents. The study will observe patients who have experienced stent blockages in specific deep vein segments of the lower extremities. Participants will be monitored to assess the catheter's performance and outcomes related to the treatment of these blockages. The study is observational, meaning it will collect data without altering the standard treatment protocols.

Why it matters

Who can join: the full rules

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

Where it's running

• Yale University
  New Haven, Connecticut, United States Recruiting
• Medstar Health Research Institute
  Washington D.C., District of Columbia, United States Recruiting
• St. Luke's Hospital Boise
  Boise, Idaho, United States Recruiting
• University of Maryland
  Baltimore, Maryland, United States Recruiting
• New York University- Langone
  New York, New York, United States Recruiting
• Mission Health
  Asheville, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Jenifer Foss
• Email: jenifer.foss@stryker.com
• Phone: (978)-587-6598

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Comparison of ClotTriever System and Anticoagulation for Deep Vein Thrombosis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.