FlowTriever2 Pulmonary Embolectomy Clinical Study

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Inari Medical
Study ID
NCT05560763
Status
Completed

Conditions

  • Pulmonary Embolism

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • FlowTriever2 Catheter — DEVICE
    The FlowTriever2 Catheter is utilized for the treatment of Pulmonary Embolism via mechanical thrombectomy of thrombus in the pulmonary arteries.

Study Details

The FLARE-FT2 confirmatory study is a prospective, single-arm, multicenter study of the FlowTriever2 Catheter for mechanical thrombectomy of pulmonary embolism (PE).

Key Dates

First listed
Sep 29, 2022
Start date
Feb 14, 2023
Status verified
Sep 2025
Primary completion
Sep 9, 2024
Completion
Sep 9, 2024

Study Design

Enrollment
50 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: All Subjects
    All participants who were treated with the FlowTriever System and FlowTriever2 Catheter.

Primary Outcome Measure

Primary Safety Endpoint (Composite): Incidence of Adjudicated Serious Adverse Events (SAE) [ Time Frame: Device-related mortality and device-related major bleeding components assessed through 48 hours after index procedure. Intra-procedural device or procedure-related AE component assessed until index procedure completion (index procedure: approx. 50 mins). ]

Locations (7)

FacilityCityStateZIPSite coordinators
Carondelet St. Joseph's HospitalTucsonArizona85711-
Yale UniversityNew HavenConnecticut06511-
Memorial Health University Medical CenterSavannahGeorgia31404-
Baptist HealthLouisvilleKentucky40207-
Virtua HealthCamdenNew Jersey08103-
Oklahoma Heart InstituteTulsaOklahoma74104-
University of Tennessee Medical CenterKnoxvilleTennessee37920-

Find similar trials in Tucson, AZ

By research site
Carondelet St. Joseph's Hospital· Tucson, AZYale University· New Haven, CTMemorial Health University Medical Center· Savannah, GABaptist Health· Louisville, KYVirtua Health· Camden, NJOklahoma Heart Institute· Tulsa, OK

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