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Pulmonary Embolism (PE)PENCT07681154

Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism

A study testing Thrombolysis Catheter in people with Pulmonary Embolism (PE) and Pulmonary Embolism With Right Ventricle Enlargement, run by Flow Medical Solutions, Inc..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a pilot study of the Flow Medical Catheter, a catheter-based device used to deliver clot-dissolving medication directly to a blood clot in the lungs (pulmonary embolism). The study evaluates whether the device can be used safely and as intended in adults with intermediate-risk acute pulmonary embolism. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Thrombolysis Catheter
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
Oct 2026to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet ALL of the following criteria to be eligible:
  • Age 18 to 75 years, inclusive.
  • Clinical signs and/or symptoms consistent with acute PE with symptom onset ≤14 days prior to baseline CTPA.
  • CTPA demonstrating acute PE with a filling defect in at least one main or lobar pulmonary artery.
  • RV/LV diameter ratio ≥0.9 on baseline CTPA (site read acceptable for eligibility determination).
  • Medically eligible for CDT and standard anticoagulation per institutional guidelines and the treating investigator's judgment.
  • Willing and able to provide written informed consent and comply with all study procedures and follow-up requirements.

Who cannot join

  • Subjects meeting ANY of the following criteria are not eligible:
  • High-risk (massive) PE: Sustained SBP <90 mmHg for ≥15 consecutive minutes, >40 mmHg drop from baseline, vasopressor requirement, or cardiac arrest requiring cardiopulmonary resuscitation during the immediate hospitalization.
  • Respiratory insufficiency: FiO₂ requirement >40% or >6 LPM supplemental oxygen to maintain SpO₂ >90%.
  • Prior PE: Prior PE ≤180 days from index procedure.
  • Absolute contraindications to thrombolytic therapy:
  • Any prior intracranial hemorrhage (no time limit)
Show all 56Show fewer
  • Known structural cerebrovascular lesion or arteriovenous malformation (no time limit)
  • Known malignant intracranial neoplasm (no time limit)
  • Ischemic stroke or TIA within 3 months of baseline CTPA
  • Intracranial or intraspinal surgery within 2 months of baseline CTPA
  • Significant closed-head or facial trauma within 3 months of baseline CTPA
  • Suspected aortic dissection
  • Active bleeding or bleeding diathesis (excluding menses)
  • Active intracranial or intraspinal disease
  • Irreversible neurological compromise
  • Relative contraindications to thrombolytic therapy:
  • Severe uncontrolled hypertension at presentation (SBP >180 mmHg or DBP >110 mmHg)
  • Major surgery within 3 weeks of baseline CTPA
  • Major trauma (non-intracranial) within 3 months of baseline CTPA
  • Traumatic or prolonged CPR (>10 minutes) within 3 weeks of baseline CTPA
  • Recent internal bleeding within 4 weeks of baseline CTPA
  • Noncompressible vascular puncture site(s)
  • Active peptic ulcer
  • Ischemic stroke more than 3 months prior to baseline CTPA
  • Laboratory exclusions (within 6 hours of index procedure, not correctable prior to procedure):
  • Platelet count <100,000/µL
  • Hemoglobin <8.0 g/dL
  • INR >2.0; or INR >1.5 if currently receiving warfarin
  • aPTT >50 seconds in the absence of anticoagulant therapy
  • eGFR <30 mL/min/1.73 m²
  • Cardiac and pulmonary exclusions:
  • Known LVEF ≤30% by any imaging modality
  • Decompensated heart failure at presentation requiring inotropic or diuretic escalation unrelated to the index PE procedure
  • History of chronic lung disease requiring supplemental oxygen therapy at baseline
  • Known chronic severe pulmonary hypertension not attributable to the index PE episode (documented PASP >70 mmHg by right heart catheterization or echocardiography, or documented CTEPH)
  • Profound bradycardia requiring temporary pacing or inotropic support
  • Procedural and anatomical exclusions:
  • Known or suspected clot in transit (right atrium or right ventricle), IVC clot, or intracardiac thrombus
  • Intracardiac lead in the right ventricle or right atrium placed ≤180 days prior to the index procedure
  • Actively progressing cancer actively treated with chemotherapy
  • Anatomic or clinical conditions precluding safe venous access or catheter delivery to the pulmonary arteries
  • BMI >45 kg/m² if, in the judgment of the investigator, body habitus poses unacceptable risk for vascular access, catheter delivery, or procedural bleeding management
  • Device and drug hypersensitivity:
  • Allergy or hypersensitivity to rt-PA (alteplase)
  • Heparin allergy or history of heparin-induced thrombocytopenia (HIT)
  • Known hypersensitivity to nitinol (nickel-titanium alloy)
  • Known anaphylactic reaction to radiographic contrast agents not amenable to premedication
  • Prior thrombolytic use or glycoprotein IIb/IIIa inhibitor use within 3 days of baseline CTPA.
  • Use of a direct oral anticoagulant (DOAC) within 48 hours of the index procedure, unless the investigator judges procedural bleeding risk to be acceptable and documents this determination, with rationale, in the subject's medical record.
  • Pregnancy. A pregnancy test is required for all women of childbearing potential prior to enrollment; point-of-care testing is acceptable. Patients with a positive pregnancy test are excluded. Postpartum patients are eligible if all other criteria are met.
  • Life expectancy <90 days in the investigator's judgment.
  • Concurrent enrollment in another interventional clinical investigation.
  • Previous enrollment in this study.
  • Absolute contraindication to anticoagulation, or inability to receive post-procedure anticoagulation per institutional standard of care.
  • Unable or unwilling to provide written informed consent.
  • In the opinion of the investigator, the subject is at unacceptably high risk for bleeding complications or is otherwise not a suitable candidate for the study

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Bryan Wylie contact

+1 650 224 5810

clinical@flowmedical.co

About this study

Official title: Pilot Study to Evaluate the Safety and Feasibility of the Flow Medical Catheter for Catheter-Directed Thrombolysis in Acute Intermediate-Risk Pulmonary Embolism

This is a pilot study of the Flow Medical Catheter, a catheter-based device used to deliver clot-dissolving medication directly to a blood clot in the lungs (pulmonary embolism). The study evaluates whether the device can be used safely and as intended in adults with intermediate-risk acute pulmonary embolism. All participants receive treatment with the study device; there is no comparison group.

Read the detailed description

This single-arm, pilot study evaluates the safety and feasibility of the Flow Medical Catheter for catheter-directed thrombolysis in adults with acute intermediate-risk pulmonary embolism. Participants undergo the catheter-directed thrombolysis procedure with the study device and are followed for procedure-related safety outcomes during the early post-procedure period. Eligibility criteria, study intervention, and outcome measures are described in the corresponding structured sections of this record.

Being tested
Thrombolysis Catheter
Keywords
catheter directed thrombolysis, lysis, lytics, thrombolysis
Medical subject headings
Pulmonary Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thrombolysis CatheterDevice

    Also called PE Catheter, Catheter Directed Thrombolysis

    Catheter-directed thrombolysis is performed using the Flow Medical Catheter to deliver a thrombolytic agent directly into the pulmonary arteries. The device is positioned at the target site, and thrombolytic infusion is delivered per the study protocol.

Study groups in NCT07681154
Study groupRoleWhat they receive
Catheter-Directed Thrombolysis (Flow Medical Catheter)ExperimentalAll participants undergo catheter-directed thrombolysis with the Flow Medical Catheter for treatment of acute intermediate-risk pulmonary embolism. This is a single-arm study; all enrolled participants receive the same study intervention.
Receives: Device: Thrombolysis Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of device-related serious adverse events (SAEs)

    Number of participants experiencing one or more serious adverse events assessed as related to the study device.

    Measured: 72 hours post procedure

  2. Successful device deployment and thrombolytic infusion

    Proportion of participants in whom the Flow Medical scaffold is successfully deployed and expanded within the target pulmonary artery, with confirmed initiation and maintenance of thrombolytic infusion through the device for the protocol-specified duration.

    Measured: Index Procedure through 24 hours post

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07681154
Sponsor's protocol ID
FM095
Acronym
PE
Status last verified
Jun 2026
First submitted
26 Jun 2026
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Thrombolysis Catheter in people with Pulmonary Embolism (PE) and Pulmonary Embolism With Right Ventricle Enlargement, run by Flow Medical Solutions, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 56 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bryan Wylie (+1 650 224 5810, clinical@flowmedical.co), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of device-related serious adverse events (SAEs) (time frame: 72 hours post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07681154.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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