Clinical trial NCT06672510: Safety and Effectiveness of the Akura Thrombectomy System for Use in the Removal of Emboli From the Pulmonary Arteries in Treating Acute Pulmonary Embolism (PE)
Official title: Safety and Effectiveness of the Akura Thrombectomy System for Use in the Removal of Emboli From the Pulmonary Arteries in Treating Acute Pulmonary Embolism (PE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Embolism Acute
Lead sponsor: Akura Medical
Sponsor class: INDUSTRY
First posted: 2024-11-04
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a prospective, single-arm, interventional, multicenter study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy System in subjects with acute pulmonary embolism (PE).


Eligibility criteria: Inclusion Criteria:

* The patient is 18 years of age or older and deemed medically eligible for interventional procedure, per institutional guidelines and clinical judgement
* Clinical signs, symptoms and presentation consistent with acute PE
* PE symptom duration ≤ 14 days
* CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
* CTA evidence of RV/LV ratio of ≥ 0.9 (NOTE: Enrollment qualification assessment is based on the Investigator's interpretation of RV/LV ratio at baseline)
* Systolic BP ≥ 90 mmHg (initial SBP may be \< 90 mmHg but ≥ 80 mmHg if the pressure recovers with volume resuscitation)
* Stable HR \< 130 BPM prior to the procedure

Exclusion Criteria:

* Prior PE \<180 days from index procedure
* Thrombolytic use within 30 days prior to baseline CTA
* Pulmonary hypertension with peak pulmonary arterial pressure (PAP) \> 70 mmHg by right heart catheterization
* Vasopressor requirement after fluids to keep pressure at ≥ 90 mmHg
* FiO2 requirement \> 40% or \> 6 LPM (to keep oxygen saturation \> 90%)
* Hematocrit \< 28% (Note: hematocrit required within 6 hrs. of index procedure)
* Platelets \< 100,000/μL
* eGFR \<30 ml/min per 1.73 m2
* International normalized ratio (INR) \> 3
* Major trauma injury severity score (ISS) \> 15
* Presence of intracardiac lead in right ventricle or atrium placed ≤ 6 months of enrollment
* Cardiovascular or pulmonary surgery within the last 7 days
* Actively progressing cancer treated by chemotherapeutics
* Known bleeding diathesis or coagulation disorder
* Left bundle branch block
* History of severe or chronic pulmonary arterial hypertension
* History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
* History of uncompensated heart failure.
* History of underlying lung disease that is oxygen dependent
* History of chest irradiation
* History of heparin-induced thrombocytopenia (HIT)
* Contraindication to systemic or therapeutic doses of anticoagulants
* Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
* Known residual iliac deep vein thrombosis (DVT), inferior vena cava (IVC) clot or clot in transit (right atrium and/or right ventricle)
* CTA imaging or other evidence that suggest, in the opinion of the investigator, the Subject is not appropriate for mechanical thrombectomy intervention (e.g. inability to navigate to target location, predominantly chronic clot or non-clot embolus)
* Life expectancy \< 90 days, as determined by investigator (e.g., stage 4 cancer, frailty or severe COVID infections)
* Female who is pregnant or nursing
* Current participation in another investigational drug or device treatment study

Primary outcomes:
measure: Effectiveness
timeFrame: 48 hours
measure: Safety: Composite of Major Adverse Device-Related Events
timeFrame: 48 hours post index procedure
Secondary outcomes:
measure: Safety: Composite of Major Adverse Events
timeFrame: 30 days post index procedure
Other outcomes:
Locations:
city: Thousand Oaks
country: United States
facility: Los Robles Regional Medical Center
state: California
city: Thornton
country: United States
facility: Advanced Heart & Vein (ClinRe-001-001)
state: Colorado
city: Hartford
country: United States
facility: Hartford Healthcare
state: Connecticut
city: New York
country: United States
facility: Cumc/Nyph
state: New York
city: Toledo
country: United States
facility: ProMedica Toledo Hospital
state: Ohio
city: Nashville
country: United States
facility: Tristar Centennial Medical Center
state: Tennessee
city: San Antonio
country: United States
facility: Methodist San Antonio (HCA)
state: Texas
Study officials:
References: