RevCore for In Stent Thrombosis
Purpose
The purpose of this research is to collect information about how the RevCore Thrombectomy Catheter works to treat stent blockages.
Condition
- In-stent Thrombosis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Recruiting Locations
Yale University
New Haven, Connecticut 06511
New Haven, Connecticut 06511
Contact:
Angelo Marino, OD
Angelo Marino, OD
Medstar Health Research Institute
Washington D.C., District of Columbia 20010
Washington D.C., District of Columbia 20010
Contact:
Kyle Reynolds, MD
Kyle Reynolds, MD
St. Luke's Hospital Boise
Boise, Idaho 83712
Boise, Idaho 83712
Contact:
Tyler Harris, MD
Tyler Harris, MD
University of Maryland
Baltimore, Maryland 21201
Baltimore, Maryland 21201
Contact:
Khanjan Nagarsheth, MD
Khanjan Nagarsheth, MD
New York University- Langone
New York, New York 10016
New York, New York 10016
Contact:
Mikel Sadek, MD
Mikel Sadek, MD
Mission Health
Asheville, North Carolina 28801
Asheville, North Carolina 28801
Contact:
Trevor Downing, MD
Trevor Downing, MD
UH Cleveland Medical Center
Cleveland, Ohio 44106
Cleveland, Ohio 44106
Contact:
Karem Harth, MD
Karem Harth, MD
Ohio State University
Columbus, Ohio 23210
Columbus, Ohio 23210
Contact:
Mina Makary, MD
Mina Makary, MD
University of Pennsylvania
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Contact:
Ryan Cobb, MD
Ryan Cobb, MD
Allegheny Health Network Research Institute
Pittsburgh, Pennsylvania 15212
Pittsburgh, Pennsylvania 15212
Contact:
Abdullah Shaikh, MD
Abdullah Shaikh, MD
Spartanburg Medical Center
Spartanburg, South Carolina 29303
Spartanburg, South Carolina 29303
Contact:
Brian Brown, MD
Brian Brown, MD
El Paso Cardiology Associates
El Paso, Texas 79902
El Paso, Texas 79902
Contact:
Waseem Shami, MD
Waseem Shami, MD
Baylor Scott & White Research Institute
Plano, Texas 75093
Plano, Texas 75093
Contact:
Joseph Liechty, MD
Joseph Liechty, MD
Sentara
Norfolk, Virginia 23507
Norfolk, Virginia 23507
Contact:
David Dexter, MD
David Dexter, MD
University of Washington
Seattle, Washington 98133
Seattle, Washington 98133
Contact:
Jake Hemingway, MD
Jake Hemingway, MD
West Virginia University- Ruby Memorial
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
Contact:
Robert Grammer, MD
Robert Grammer, MD
More Details
- Status
- Recruiting
- Sponsor
- Inari Medical