FlowTriever All-Comer Registry for Patient Safety and Hemodynamics

PE - Pulmonary Thromboembolism Clinical Trial

— FLASH  

Official title:

FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03761173
• Other study ID #: 18-002
• Status: Active, not recruiting
• Start date: December 15, 2018
• Est. completion date: October 31, 2024

Study information

• Verified date: April 2024
• Source: Inari Medical
• Contact: n/a
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Embolism
• PE - Pulmonary Embolism
• PE - Pulmonary Thromboembolism
• Pulmonary Embolism
• Thromboembolism

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