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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥ 18 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up length of index hospitalization, length of hospitalization median of 9.1 days, length of icu stay median 3.1 per jns
Awards & highlights
Study Summary
This trial is testing a device to treat people with a specific kind of blood clot.
Who is the study for?
This trial is for adults with low-risk submassive pulmonary embolism, which means they have certain heart strain or dilation and elevated heart-related proteins in their blood. They must be stable and not severely ill with COVID-19, pregnant, breastfeeding, unable to consent or take blood thinners.Check my eligibility
What is being tested?
The study tests the FlowTriever device's effectiveness and safety in treating low-risk submassive pulmonary embolism by removing clots from lung arteries without surgery.See study design
What are the potential side effects?
While specific side effects are not listed here, interventions like FlowTriever may cause discomfort at the insertion site, bleeding complications, or reactions related to clot removal.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ length of index hospitalization, length of hospitalization median of 9.1 days, length of icu stay median 3.1 per jns
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~length of index hospitalization, length of hospitalization median of 9.1 days, length of icu stay median 3.1 per jns
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in mMRC dyspnea score from
Secondary outcome measures
All-cause Mortality
Bleeding Re-thrombosis Edema Pain
Change in Pulmonary Embolism Quality of Life Questionnaire (PEmbQOL)
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: FlowTrieverExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Northwell HealthLead Sponsor
458 Previous Clinical Trials
470,903 Total Patients Enrolled
1 Trials studying Pulmonary Embolism
31 Patients Enrolled for Pulmonary Embolism
Inari MedicalIndustry Sponsor
11 Previous Clinical Trials
4,331 Total Patients Enrolled
8 Trials studying Pulmonary Embolism
3,521 Patients Enrolled for Pulmonary Embolism
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to give consent by myself.Only subsegmental pulmonary embolism cases will be excluded.I do not have a severe or active COVID-19 infection.I have a low-risk type of lung blood clot according to specific health guidelines.I am 18 years old or older.You are expected to live for less than 6 months.I cannot use blood thinners like heparin.You are allergic to the dye used in certain medical imaging tests, and cannot take medication to prevent an allergic reaction.
Research Study Groups:
This trial has the following groups:- Group 1: FlowTriever
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.
Are there any open slots available for this research endeavor?
"This clinical trial, which was initially posted on the 25th of January 2022, is recruiting patients and its information has been recently updated as of September 22nd."
Answered by AI
What is the maximum enrollment capacity for this trial?
"Affirmative. The information posted on clinicaltrials.gov demonstrates that this research study is actively recruiting patients, with the initial posting occurring on January 25th 2022 and the last update taking place on September 22nd 2022. This trial has a target of 30 subjects from one location."
Answered by AI
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