PEERLESS II - Comparison of the FlowTriever System and Treatment with Anticoagulant Medications

ID di studio ICTRP
NCT06055920 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
PEERLESS II - RCT of FlowTriever vs. Anticoagulation alone in Pulmonary Embolism (BASEC)

Titolo accademico
PEERLESS II: RCT of FlowTriever vs. Anticoagulation Alone in Pulmonary Embolism (ICTRP)

Titolo pubblico
The PEERLESS II Study (ICTRP)

Malattie studiate
Pulmonary Embolism (ICTRP)

Intervento studiato
Device: FlowTriever SystemDrug: Anticoagulation Agents (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Criteri di inclusione/esclusione
Inclusion Criteria:

1. Age at enrollment = 18 years

2. 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

3. RV dysfunction, as defined as one or more of the following: RV/LV ratio = 0.9 or RV
dilation or hypokinesis

4. 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

5. Symptom onset within 14 days of confirmed PE diagnosis

6. Willing and able to provide informed consent

Exclusion Criteria:

1. Unable to be anticoagulated with heparin, enoxaparin or other parenteral
antithrombin

2. Presentation with hemodynamic instability* that meets the high-risk PE definition in
the 2019 ESC Guidelines1, including ANY of the following

1. Cardiac arrest OR

2. Systolic BP < 90 mmHg or vasopressors required to achieve a BP = 90 mmHg
despite adequate filling status, AND end-organ hypoperfusion OR

3. 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.

3. Known sensitivity to radiographic contrast agents that, in the Investigator's
opinion, cannot be adequately pre-treated

4. 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)

5. End stage medical condition with life expectancy < 3 months, as determined by the
Investigator

6. Current participation in another drug or device study that, in the investigator's
opinion, would interfere with participation in this study

7. Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or
chronic thromboembolic disease (CTED) diagnosis, per 2019 ESC Guidelines1

8. 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

9. 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

10. Ventricular arrhythmias refractory to treatment at the time of enrollment

11. Known to have heparin-induced thrombocytopenia (HIT)

12. 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

13. Subject is currently pregnant

14. Subject has previously completed or withdrawn from this study (ICTRP)

non disponibile

Endpoint primari e secondari
Composite clinical endpoint constructed as a win ratio, a hierarchy of the following, which are assessed post-randomization: (ICTRP)

Composite clinical endpoint constructed as a win ratio hierarchy of the following three components, assessed post randomization:;All-cause and PE-related mortality;All-cause and PE-related readmissions;Clinical deterioration;Bailout therapy;Major Bleeding, defined by the Bleeding Academic Research Consortium (BARC), level 3b, 3c, 5a, or 5b;Dyspnea severity by mMRC score;PE-related quality of life, by PEmb-QoL;General health-related quality of life, by EQ-5D-5L;6-minute walk distance;RV/LV ratio;Post-PE Impairment diagnosis (PPEI) (ICTRP)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
Frances Mae West, MD;Jay Giri, MD;Bernhard Gebauer, MD;Felix Mahfoud, MD;Cassandra Gamble, cassandra.gamble@inarimedical.com, 651-900-5294, Jefferson Health,,Penn Medicine,Charit? University Hospital Berlin,Saarland University Hospital Homburg, (ICTRP)

ID secondari
23-001 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06055920 (ICTRP)