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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03761173
Other study ID # 18-002
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 15, 2018
Est. completion date October 31, 2024

Study information

Verified date May 2024
Source Inari Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

To evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism (PE). The use of the device will be assessed in a real-world population, with eligibility criteria that closely approximate its use in clinical practice. Up to 300 additional patients with anticoagulation treatment as the initial planned primary treatment strategy for intermediate risk PE will also be evaluated (US only).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1300
Est. completion date October 31, 2024
Est. primary completion date October 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Clinical signs and symptoms consistent with acute PE - Echo, CTPA or pulmonary angiographic evidence of proximal filling defect in at least one main or lobar pulmonary artery - Scheduled for PE treatment with the FlowTriever System per the Investigator's discretion* - US only: Patients enrolled in the Conservative Therapy Sub-study are not required to meet this inclusion criteria but must instead be scheduled for primary anticoagulation therapy as the primary treatment strategy. Exclusion Criteria: - Unable to be anticoagulated with heparin or alternative - Diagnosis with a minor PE with a less than 0.9 RV/LV ratio - Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated* - Imaging evidence or other evidence that suggests, in the Investigator's opinion, the subject is not appropriate for mechanical thrombectomy intervention* - Life expectancy < 30 days, as determined by Investigator - Current participation in another investigational drug or device treatment study that, in the Investigator's opinion, would interfere with participation in this study - US Only Patients enrolled in the Conservative Therapy Sub-study are not required to meet these exclusion criteria

Study Design


Intervention

Device:
FlowTriever System
Thrombectomy
Drug:
Anticoagulation Agents
Anticoagulation medication

Locations

Country Name City State
Austria Allgemeines Krankenhaus AKH Wien Vienna
Belgium UZ Antwerpen Antwerpen
Belgium UZ Brussel Brussel
France Centre Hospitalier Universitaire de Besançon Besançon
France Hopital de la Cavale Blanche - CHU Brest Brest
France CHU Grenoble Grenoble
France Institut Coeur Poumon - CHU de Lille Lille
France HCL Hôpital Louis Pradel - Hôpital Cardiologique Lyon
France European Hospital Georges Pompidou Paris
Germany Charité Hospital - Campus Virchow-Klinikum Berlin
Germany Cardioangiologisches Centrum Bethanien Frankfurt
Germany University Hospital Heidelberg
Germany Universitatsklinikum des Saarlandes Homburg
Germany Helios Kliniken Schwerin Schwerin
Netherlands Universitair Medisch Centrum Utrecht Utrecht
Spain Gregorio Maranon University Hospital Madrid
Spain Hospital Clínico San Carlos Madrid
Switzerland Inselspital Bern
Switzerland Kantonsspital Sankt Gallen Saint Gallen
Switzerland Unispital Zürich
United Kingdom The Royal Free Hospital London
United Kingdom The Royal London Hospital, Bart's Health London
United States Albany Medical Center Albany New York
United States Emory University Atlanta Georgia
United States University of Colorado Aurora Colorado
United States UAB Division of Cardiovascular Disease Birmingham Alabama
United States SUNY, The University at Buffalo Buffalo New York
United States Rush Medical Center Chicago Illinois
United States University of Chicago Chicago Illinois
United States University Hospitals Cleveland Medical Center Cleveland Ohio
United States Missouri Cardiovascular Specialists Columbia Missouri
United States University of Missouri, Columbia Columbia Missouri
United States CardioVoyage Denison Texas
United States Henry Ford Health System Detroit Michigan
United States Northwestern University Evanston Illinois
United States Providence Regional Medical Center Everett Everett Washington
United States Inova Fairfax Falls Church Virginia
United States Methodist Healthcare Foundation Germantown Tennessee
United States Ascension Genesys Hospital Grand Blanc Michigan
United States Indiana University School of Medicine Indianapolis Indiana
United States Memorial Hospital Jacksonville Jacksonville Florida
United States UTMC Knoxville Knoxville Tennessee
United States Lakeland Vascular Institute Lakeland Florida
United States Saint Luke's Hospital of Kansas City Lee's Summit Missouri
United States Baptist Health Lousville Louisville Kentucky
United States Norton Healthcare Louisville Kentucky
United States Ascension Providence Hospital Madison Heights Michigan
United States Northwell Health Manhasset New York
United States Mount Sinai Medical Center of Florida Miami Florida
United States Palmetto General Hospital Miami Florida
United States University of Miami Miami Florida
United States Aurora St. Luke's Medical Center Milwaukee Wisconsin
United States Metropolitan Heart and Vascular Institute Minneapolis Minnesota
United States University of Minnesota Minneapolis Minnesota
United States St. Thomas West Nashville Tennessee
United States Yale University New Haven Connecticut
United States Mount Sinai New York New York
United States NYU Langone Medical Center New York New York
United States Christiana Care Health Services Newark Delaware
United States Sentara Norfolk Virginia
United States Opelousas General Opelousas Louisiana
United States Ascension Sacred Heart Pensacola Florida
United States Thomas Jefferson University Philadelphia Pennsylvania
United States University of Pennsylvania Philadelphia Pennsylvania
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Jamaica Hospital Queens New York
United States Valley Health Ridgewood New Jersey
United States Ascension Providence Rochester Hospital Rochester Michigan
United States Javon Bea Hospital Rockford Illinois
United States St. Francis Hospital & Heart Center Roslyn New York
United States Beaumont Health Royal Oak Michigan
United States CentraCare Heart & Vascular Center Saint Cloud Minnesota
United States Sarasota Memorial Hospital Sarasota Florida
United States Providence Sacred Heart Spokane Washington
United States Tallahassee Memorial Hospital Tallahassee Florida
United States Pima Heart and Vascular Tucson Arizona
United States University of Arizona College of Medicine Tucson Arizona
United States Westchester Medical Center Valhalla New York
United States Lexington Medical Center West Columbia South Carolina
United States Wake Forest Baptist Medical Center Winston-Salem North Carolina
United States St. Joseph Mercy Ypsilanti Michigan

Sponsors (1)

Lead Sponsor Collaborator
Inari Medical

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  France,  Germany,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

References & Publications (5)

Bangalore S, Horowitz JM, Beam D, Jaber WA, Khandhar S, Toma C, Weinberg MD, Mina B. Prevalence and Predictors of Cardiogenic Shock in Intermediate-Risk Pulmonary Embolism: Insights From the FLASH Registry. JACC Cardiovasc Interv. 2023 Apr 24;16(8):958-972. doi: 10.1016/j.jcin.2023.02.004. — View Citation

Horowitz JM, Jaber WA, Stegman B, Rosenberg M, Fanola C, Bhat AP, Gondi S, Castle J, Ahmed M, Brown MA, Amin R, Bisharat M, Butros P, DuCoffe A, Savin M, Pollak JS, Weinberg MA, Brancheau D, Toma C. Mechanical Thrombectomy for High-Risk Pulmonary Embolism: Insights From the US Cohort of the FLASH Registry. JSCAI. 2023. (in press) doi: 10.1016/j.jscai.2023.101124

Khandhar S, Jaber W, Bunte MC, Cho K, Weinberg MD, Mina B, Stegman B, Pollak J, Khosla A, Elmasri F, Zlotnick D, Brancheau D, Koenig G, Bisharat M, Li J, Toma C. Longer-Term Outcomes Following Mechanical Thrombectomy for Intermediate- and High-Risk Pulmonary Embolism: 6-Month FLASH Registry Results. JSCAI. 2023. 2:101000. doi: 10.1016/j.jscai.2023.101000

Toma C, Bunte MC, Cho KH, Jaber WA, Chambers J, Stegman B, Gondi S, Leung DA, Savin M, Khandhar S, Kado H, Koenig G, Weinberg M, Beasley RE, Roberts J, Angel W, Sarosi MG, Qaqi O, Veerina K, Brown MA, Pollak JS. Percutaneous mechanical thrombectomy in a real-world pulmonary embolism population: Interim results of the FLASH registry. Catheter Cardiovasc Interv. 2022 Mar;99(4):1345-1355. doi: 10.1002/ccd.30091. Epub 2022 Feb 3. — View Citation

Toma C, Jaber WA, Weinberg MD, Bunte MC, Khandhar S, Stegman B, Gondi S, Chambers J, Amin R, Leung DA, Kado H, Brown MA, Sarosi MG, Bhat AP, Castle J, Savin M, Siskin G, Rosenberg M, Fanola C, Horowitz JM, Pollak JS. Acute outcomes for the full US cohort of the FLASH mechanical thrombectomy registry in pulmonary embolism. EuroIntervention. 2023 Feb 20;18(14):1201-1212. doi: 10.4244/EIJ-D-22-00732. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Composite Major Adverse Events Rate of subjects with composite of device-related death, major bleeding, device or procedure-related adverse events 48-hours
Secondary Individual Major Adverse Events Rate of subjects with individual components of composite MAE 48-hours
Secondary All-cause mortality Rate of deaths 30-days
Secondary Device-related serious adverse events Rate of device-related SAEs 30-days
See also
  Status Clinical Trial Phase
Completed NCT04795167 - FLowTriever for Acute Massive Pulmonary Embolism (FLAME)
Withdrawn NCT03027167 - Outcomes Study in Patients Receiving Aspirin With Mechanical Compression Devices Versus Aspirin Alone Following Knee and Hip Arthroplasty Phase 4
Not yet recruiting NCT05992168 - Stent-Retriever for Acute Massive Pulmonary Embolism (SRAME) N/A