FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03761173 |
Recruitment Status :
Enrolling by invitation
First Posted : December 3, 2018
Last Update Posted : December 2, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
PE - Pulmonary Embolism PE - Pulmonary Thromboembolism | Device: FlowTriever System |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 500 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 6 Months |
Official Title: | FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH) |
Actual Study Start Date : | December 15, 2018 |
Estimated Primary Completion Date : | June 30, 2021 |
Estimated Study Completion Date : | December 31, 2021 |

- Device: FlowTriever System
Thrombectomy
- Composite Major Adverse Events [ Time Frame: 48-hours ]Rate of subjects with composite of device-related death, major bleeding, device or procedure-related adverse events
- Individual Major Adverse Events [ Time Frame: 48-hours ]Rate of subjects with individual components of composite MAE
- All-cause mortality [ Time Frame: 30-days ]Rate of deaths
- Device-related serious adverse events [ Time Frame: 30-days ]Rate of device-related SAEs

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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
Exclusion Criteria:
- Unable to be anticoagulated with heparin or alternative
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03761173

Responsible Party: | Inari Medical |
ClinicalTrials.gov Identifier: | NCT03761173 |
Other Study ID Numbers: |
18-002 |
First Posted: | December 3, 2018 Key Record Dates |
Last Update Posted: | December 2, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
PE pulmonary embolism thromboembolism thrombectomy FlowTriever |
Pulmonary Embolism Thromboembolism Embolism Embolism and Thrombosis |
Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |