Clinical Trials in the USA / NCT06394739
Recruiting
Observational
RevCore for In Stent Thrombosis
NCT06394739 · tracked via the Priya Life Science USA tracker
Condition(s) studied
In-stent Thrombosis
Investigational drug(s) / intervention(s)
Thrombectomy
Thrombectomy: RevCore Thrombectomy to treat in-stent thrombosis
Study summary
The purpose of this research is to collect information about how the RevCore Thrombectomy Catheter works to treat stent blockages.
Eligibility
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
Primary outcome measure(s)
- Evidence of successful stent recanalization — Immediately after the RevCore thrombectomy procedure for in-stent thrombosis
Defined as patency ≥50% luminal diameter utilizing intravascular ultrasound (IVUS)
Trial sites (17)
| Facility | City | Region | Status |
|---|---|---|---|
| Yale University | New Haven | Connecticut | Recruiting |
| Medstar Health Research Institute | Washington D.C. | District of Columbia | Recruiting |
| St. Luke's Hospital Boise | Boise | Idaho | Recruiting |
| University of Maryland | Baltimore | Maryland | Recruiting |
| New York University- Langone | New York | New York | Recruiting |
| Mission Health | Asheville | North Carolina | Recruiting |
| UH Cleveland Medical Center | Cleveland | Ohio | Recruiting |
| Ohio State University | Columbus | Ohio | Recruiting |
| University of Pennsylvania | Philadelphia | Pennsylvania | Recruiting |
| Thomas Jefferson University | Philadelphia | Pennsylvania | Withdrawn |
| Allegheny Health Network Research Institute | Pittsburgh | Pennsylvania | Recruiting |
| Spartanburg Medical Center | Spartanburg | South Carolina | Recruiting |
| El Paso Cardiology Associates | El Paso | Texas | Recruiting |
| Baylor Scott & White Research Institute | Plano | Texas | Recruiting |
| Sentara | Norfolk | Virginia | Recruiting |
| University of Washington | Seattle | Washington | Recruiting |
| West Virginia University- Ruby Memorial | Morgantown | West Virginia | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06394739 on ClinicalTrials.gov ↗ ← All trials in the USA