New Haven, CTNCT06055920Now EnrollingIRB Ready

Pulmonary Embolism Clinical Trial in New Haven, CT

Access cutting-edge pulmonary embolism treatment through this clinical trial at a research site in New Haven. Study-provided care at no cost to qualified participants.

Sponsored by Inari Medical

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Expert Care in New Haven

Access pulmonary embolism specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related pulmonary embolism treatment provided free

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Check if you qualify for this pulmonary embolism clinical trial in New Haven, CT

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to New Haven

    Convenient for CT residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit New Haven site if eligible
  4. 4Begin participation

About This Pulmonary Embolism Study in New Haven

This study is a prospective, multicenter, randomized controlled trial of the FlowTriever System plus anticoagulation compared to anticoagulation alone for intermediate-risk acute PE.

Sponsor: Inari Medical

Who Can Participate

Inclusion Criteria

Age at enrollment ≥ 18 years
Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery, as confirmed by CTPA, pulmonary angiography, or other imaging modality
RV dysfunction, as defined as one or more of the following: RV/LV ratio ≥ 0.9 or RV dilation or hypokinesis
At least two additional risk factors, identified by at least one measure in two separate categories noted below: a. Hemodynamic: i. SBP 90-100mmHg ii. Resting heart rate \> 100 bpm b. Biomarker: i. Elevated\
cardiac troponin (troponin I or troponin T, conventional or high sensitivity) ii. Elevated\
BNP or NT-proBNP iii. Elevated venous lactate ≥2 mmol/L \
Elevated, meaning at or above the upper limit of normal, per local standards for the assay used c. Respiratory: i. O2 saturation \< 90% on room air ii. Supplemental O2 requirement ≥ 4 L/min iii. Respiratory rate ≥ 20 breaths/min iv. mMRC score \> 0
Symptom onset within 14 days of confirmed PE diagnosis
Willing and able to provide informed consent

Exclusion Criteria

Unable to be anticoagulated with heparin, enoxaparin or other parenteral antithrombin
Presentation with hemodynamic instability\
that meets the high-risk PE definition in the 2019 ESC Guidelines1, including ANY of the following
Cardiac arrest OR
Systolic BP \< 90 mmHg or vasopressors required to achieve a BP ≥ 90 mmHg despite adequate filling status, AND end-organ hypoperfusion OR
Systolic BP \< 90 mmHg or systolic BP drop ≥ 40 mmHg, lasting longer than 15 min and not caused by new-onset arrhythmia, hypovolemia, or sepsis \
Patients who are stable at time of screening or randomization (i.e., SBP ≥ 90 mmHg and adequate organ perfusion without catecholamine or vasopressor infusion) may be included despite initial presentation including temporary, low-dose catecholamines or vasopressors, or temporary fluid resuscitation.
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 opinion of the Investigator, the patient is not appropriate for catheter-based intervention (e.g., inability to navigate to target location, clot limited to segmental/subsegmental distribution, predominately chronic clot)
End stage medical condition with life expectancy \< 3 months, as determined by the Investigator
Current participation in another drug or device study that, in the investigator's opinion, would interfere with participation in this study
Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis, per 2019 ESC Guidelines1
If objective testing was performed\*, estimated RV systolic pressure \> 70 mmHg on standard of care echocardiography \
If clinical suspicion of acute-on-chronic PE, chronic obstruction, or chronic thromboembolism, echocardiographic estimated RVSP must be confirmed ≤70 mmHg to meet eligibility. Pressure assessment not required if Investigator attests to absence of such clinical suspicion
Administration of advanced therapies (thrombolytic bolus, thrombolytic drip/infusion, catheter-directed thrombolytic therapy, mechanical thrombectomy, or ECMO) for the index PE event within 30 days prior to enrollment
Ventricular arrhythmias refractory to treatment at the time of enrollment
Known to have heparin-induced thrombocytopenia (HIT)
Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments). This includes a contraindication to use of FlowTriever System per local approved labeling
Subject is currently pregnant
Subject has previously completed or withdrawn from this study

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New Haven?

Yes, this clinical trial (NCT06055920) has an active research site in New Haven, CT that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Pulmonary Embolism Treatment Options in New Haven, CT

If you're searching for pulmonary embolism treatment options in New Haven, CT, this clinical trial (NCT06055920) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New Haven research site is actively enrolling participants for this clinical trial. You'll receive care from experienced pulmonary embolism specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all pulmonary embolism clinical trials near you to find additional studies recruiting in your area.

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