Clinical trial NCT06152341: Safety and Effectiveness of the ATC System in the Treatment of Acute PE
Official title: Safety and Effectiveness of the ATC System in the Treatment of Acute Pulmonary Embolism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Embolism Acute
Lead sponsor: Akura Medical
Sponsor class: INDUSTRY
First posted: 2023-11-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
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 the ATC System in subjects with acute pulmonary embolism (PE).


Eligibility criteria: Inclusion Criteria:

1. Patient is ≥ 18 and ≤ 90 years old
2. Clinical signs and symptoms consistent with acute PE for \< 14 days
3. CTA evidence of proximal PE
4. RV/LV ratio \> 0.9
5. Systolic BP ≥90 mmHg without the need for vasopressors
6. Stable heart rate (HR) \< 130 BPM prior to procedure
7. Patient is deemed medically eligible for interventional procedure(s), per investigator guidelines and clinical judgment
8. Subject or legally authorized representative (LAR) is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures

Exclusion Criteria:

1. Prior PE \< 180 days from index procedure
2. Thrombolytic use \< 30 days prior to baseline CTA
3. Pulmonary hypertension with peak pulmonary artery systolic pressure (PASP) \>70 mmHg by right heart catheterization
4. FiO2 requirement \>40% or \>6 LPM to keep oxygen saturation \>90%
5. Hematocrit \<28%
6. Platelets count \<100,000/µL
7. Serum creatinine \>1.8 mg/dL
8. International normalized ratio (INR) \>3
9. Major trauma injury severity score (ISS) \>15 prior to screening assessment
10. Presence of intracardiac lead in right ventricle or atrium placed within 6 months prior to screening assessment
11. Cardiovascular or pulmonary surgery within 7 days of index procedure
12. Actively progressing cancer treated by chemotherapeutics
13. Known bleeding diathesis or coagulation disorder
14. Left bundle branch block
15. History of severe or chronic pulmonary arterial hypertension
16. History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
17. History of decompensated heart failure
18. History of underlying lung disease that is oxygen dependent
19. History of chest irradiation
20. History of heparin-induced thrombocytopenia (HIT)
21. Contraindication to systemic or therapeutic doses of anticoagulants
22. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
23. Imaging evidence or other evidence that suggest, in the opinion of the investigator, the Subject is not appropriate for aspiration thrombectomy intervention
24. Life expectancy \<90 days, as determined by investigator such as stage 4 cancer, frailty or severe COVID infections
25. Female who is pregnant or nursing
26. Current participation in another investigational drug or device treatment study.

Primary outcomes:
measure: Effectiveness
timeFrame: 48 hours post index procedure
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: São Paulo
country: Brazil
facility: Instituto do Coracao
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
city: Santiago De Los Caballeros
country: Dominican Republic
facility: Corazones Del Cibao
state: Santiago
city: Santiago De Los Caballeros
country: Dominican Republic
facility: Centro de Intervenciones Cardiovasculares
state: Santiago
Study officials:
References: