Clinical trial NCT06394739: RevCore for In Stent Thrombosis
Official title: RevCore for In Stent Thrombosis (REVIT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: In-stent Thrombosis
Lead sponsor: Inari Medical
Sponsor class: INDUSTRY
First posted: 2024-05-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Up to 100 subjects with in-stent thrombosis will be enrolled. All subjects who sign informed consent and who meet all of the inclusion criteria and none of the exclusion criteria will be eligible to participate in the study.

Brief summary: The purpose of this research is to collect information about how the RevCore Thrombectomy Catheter works to treat stent blockages.


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

Primary outcomes:
measure: Evidence of successful stent recanalization
timeFrame: Immediately after the RevCore thrombectomy procedure for in-stent thrombosis
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Washington
country: United States
facility: Medstar Health Research Institute
state: District of Columbia
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: New York
country: United States
facility: New York University- Langone
state: New York
city: Asheville
country: United States
facility: Mission Health Hospital
state: North Carolina
city: Cleveland
country: United States
facility: UH Cleveland Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network Research Institute
state: Pennsylvania
city: Spartanburg
country: United States
facility: Spartanburg Medical Center
state: South Carolina
city: El Paso
country: United States
facility: El Paso Cardiology Associates
state: Texas
city: Morgantown
country: United States
facility: West Virginia University- Ruby Memorial
state: West Virginia
Study officials:
References: