Your session is about to expire
← Back to Search
Thrombectomy Device
FlowTriever2 Device for Pulmonary Embolism (FLARE-FT2 Trial)
N/A
Waitlist Available
Research Sponsored by Inari Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
PE symptom duration ≤ 14 days
Clinical signs and symptoms consistent with acute PE
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during procedure
Awards & highlights
FLARE-FT2 Trial Summary
This trial tests a new device to treat blocked blood vessels and stop strokes.
Who is the study for?
This trial is for adults with a recent pulmonary embolism (PE), which is a blockage in the lungs. They should have symptoms for less than 14 days, an unstable heart rate, and evidence of PE on a CT scan. Participants must not be pregnant or nursing, have severe other illnesses like active cancer or bleeding disorders, or be on certain medications that could increase risks.Check my eligibility
What is being tested?
The FlowTriever2 Catheter is being tested to see if it can safely remove blood clots from the lungs in patients with PE. This study involves one group of participants who will all receive this treatment without comparison to another intervention.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks may include bleeding at the catheter entry site, damage to blood vessels where the clot is removed, allergic reactions to materials used during the procedure, and potential complications related to heart and lung function.
FLARE-FT2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My symptoms of pulmonary embolism have been present for 2 weeks or less.
Select...
I am showing signs of a possible pulmonary embolism.
FLARE-FT2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 hours post procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours post procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effectiveness: Change in Mean Pulmonary Arterial Pressure (mmHg)
Number of Major Bleeding Occurrences
Number of Patient Mortalities (48 hours)
+1 moreSecondary outcome measures
Change in Systolic Pulmonary Arterial Pressure (mmHg)
Number of Adjunctive Thrombolytic Uses
Number of Device-Related Serious Adverse Events
+2 moreFLARE-FT2 Trial Design
1Treatment groups
Experimental Treatment
Group I: Completed CasesExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Inari MedicalLead Sponsor
11 Previous Clinical Trials
4,311 Total Patients Enrolled
8 Trials studying Pulmonary Embolism
3,501 Patients Enrolled for Pulmonary Embolism
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of heart failure that is not well-managed.Your blood test shows that your creatinine level is higher than 1.8 mg/dL.My cancer is getting worse.I have had radiation therapy to my chest in the past.You have had a severe allergic reaction to contrast agents used for medical imaging, and cannot receive pre-treatment for it.I have not had heart or lung surgery in the past week.My doctor thinks I am fit for a medical procedure.I have a bleeding or clotting disorder.My symptoms of pulmonary embolism have been present for 2 weeks or less.Your heart's right ventricle is significantly larger than the left ventricle.I have a history of bad reactions to heparin or cannot take blood thinners.You have evidence of blood clots in the main or lobar pulmonary arteries.Based on tests and images, the doctor thinks it's not a good idea to use a special device to remove a blood clot from your body.The FlowTriever2 Catheter goes into the blood vessels.You have severe injuries with a score higher than 15 on the Injury Severity Scale.Your heart rate should be less than 130 beats per minute before the procedure.I am not pregnant or nursing.You have high blood pressure in the blood vessels in your lungs, confirmed by a specific test.I need medication to maintain my blood pressure above 90 mmHg.Your hematocrit level is less than 28%.Your platelet count is less than 100,000 per microliter.You have a specific heart condition called left bundle branch block.I am showing signs of a possible pulmonary embolism.Your systolic blood pressure is at least 90 mmHg, or it's initially at least 80 mmHg and goes back up to at least 90 mmHg after getting fluids.I haven't used blood clot dissolvers in the last 30 days.I have a history of severe or long-term high blood pressure in the lungs.My heart's left chamber is weak, pumping less effectively.You have had a heart device implanted in the right side of your heart within the last 6 months.I need oxygen because of a lung condition.Your blood clotting test result (INR) is higher than 3.I need a lot of oxygen to maintain my blood oxygen levels.
Research Study Groups:
This trial has the following groups:- Group 1: Completed Cases
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is eligible to join this medical experiment?
"To be eligible, patients must have pulmonary embolism and should fall between the ages of 18 - 75. Approximately 50 individuals will be admitted to this clinical trial."
Answered by AI
Does this trial encompass those above the age of twenty?
"This trial permits patients aged 18 and 75 to participate. Notably, 6 studies are dedicated for those under the age of 18, while 70 studies cater towards participants over 65 years old."
Answered by AI
Are there currently any open opportunities to participate in this experiment?
"According to the information on clinicaltrials.gov, this trial is no longer actively seeking out participants. Initially posted in February of 2023 and most recently edited a month later, this study has since transitioned away from recruitment; however, there are currently 75 other studies that demand volunteers."
Answered by AI
What is the ultimate goal of this experiment?
"Per the research sponsor, Inari Medical, efficacy is measured by a change in Mean Pulmonary Arterial Pressure (mmHg) over 48 hours post intervention. Complementary metrics of consideration include alterations to Systolic Pulmonary Arterial Pressure (mmHg), Adjunctive Thrombolytic Uses and Device-related Serious Adverse Events in the 30 days following treatment."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger