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FLARE-FT2: FlowTriever2 Pulmonary Embolectomy Clinical Study

Sponsor
Inari Medical (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05560763
Collaborator
(none)
50
Enrollment
2
Locations
1
Arm
8.9
Anticipated Duration (Months)
25
Patients Per Site
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The FLARE-FT2 confirmatory study is a prospective, single-arm, multicenter study of the FlowTriever2 Catheter.

Condition or Disease Intervention/Treatment Phase
  • Device: FlowTriever2 Catheter
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
FlowTriever Pulmonary Embolectomy Clinical Study - FlowTriever2
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jul 30, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Completed Cases

Device: FlowTriever2 Catheter
The FlowTriever2 Catheter is utilized for the treatment of Pulmonary Embolism

Outcome Measures

Primary Outcome Measures

  1. Number of Patient Mortalities (48 hours) [48 hours post procedure]

    Mortality through 48 hours after the index procedure related to FlowTriever2 Catheter

  2. Number of Major Bleeding Occurrences [48 hours post procedure]

    Major bleeding through 48 hours after the index procedure related to FlowTriever2 Catheter

  3. Primary Safety: Serious Adverse Event 3 [Up to 30 days post procedure]

    Intra-procedural device or procedure-related adverse events, including: Clinical deterioration defined by hemodynamic or respiratory worsening Pulmonary vascular injury related to FlowTriever2 Catheter Cardiac injury related to FlowTriever2 Catheter

  4. Effectiveness: Change in Mean Pulmonary Arterial Pressure (mmHg) [During procedure]

    The study's primary effectiveness endpoint is the change in mean pulmonary arterial pressure from baseline pre-procedure and post-procedure.

Secondary Outcome Measures

  1. Number of Patient Mortalities (30 days) [Up to 30 days post procedure]

    All-cause mortality through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)

  2. Number of Device-Related Serious Adverse Events [Up to 30 days post procedure]

    Number of device-related SAE through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)

  3. Number of recurrences of PE [Up to 30 days post procedure]

    Symptomatic recurrence of pulmonary embolism through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)

  4. Change in Systolic Pulmonary Arterial Pressure (mmHg) [During procedure]

    The change in systolic pulmonary arterial pressure from baseline pre-procedure to post-procedure

  5. Number of Adjunctive Thrombolytic Uses [During procedure]

    Incidence of adjunctive thrombolytic use

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Clinical signs and symptoms consistent with acute PE

  • PE symptom duration ≤ 14 days

  • CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)

  • RV/LV ratio of ≥ 0.9 (NOTE: Enrollment qualification assessment based on Investigator's interpretation of RV/LV ratio)

  • Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids)

  • Stable heart rate < 130 BPM prior to procedure

  • Patient is deemed medically eligible for interventional procedure(s), per institutional guidelines and/or clinical judgment.

  • FlowTriever2 Catheter enters the vasculature

Exclusion Criteria:

  • Thrombolytic use within 30 days of baseline CTA

  • Pulmonary hypertension with peak pulmonary artery pressure > 70 mmHg by right heart catheterization

  • Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg

  • FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%

  • Hematocrit < 28% (NOTE: hematocrit required within 6 hours of index procedure)

  • Platelets < 100,000/μL

  • Serum creatinine > 1.8 mg/dL

  • INR > 3

  • Major trauma Injury Severity Score (ISS) > 15

  • Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months

  • Cardiovascular or pulmonary surgery within last 7 days

  • Actively progressing cancer

  • Known bleeding diathesis or coagulation disorder

  • Left bundle branch block

  • History of severe or chronic pulmonary arterial hypertension

  • History of chronic left heart disease with left ventricular ejection fraction ≤ 30%

  • History of uncompensated heart failure

  • History of underlying lung disease that is oxygen dependent

  • History of chest irradiation

  • History of heparin-induced thrombocytopenia (HIT) Any contraindication to systemic or therapeutic doses heparin or anticoagulants

  • Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated

  • Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for mechanical thrombectomy intervention (e.g., inability to navigate to target location, predominately chronic clot, or non-clot embolus)

  • Life expectancy of < 90 days, as determined by Investigator

  • Female who is pregnant or nursing

  • Current participation in another investigational drug or device treatment study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Baptist Health Louisville Kentucky United States 40207
2 Oklahoma Heart Institute Tulsa Oklahoma United States 74104

Sponsors and Collaborators

  • Inari Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Inari Medical
ClinicalTrials.gov Identifier:
NCT05560763
Other Study ID Numbers:
  • 21-001
First Posted:
Sep 29, 2022
Last Update Posted:
Jan 20, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Pulmonary Embolism
Embolism

Study Results

No Results Posted as of Jan 20, 2023