Evaluating the ATC System for treating acute pulmonary embolism

Safety and Effectiveness of the ATC System in the Treatment of Acute Pulmonary Embolism

This study is testing a new treatment system for people with acute pulmonary embolism to see if it is safe and effective.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Akura Medical (industry)
• Locations: 4 sites (São Paulo, São Paulo and 3 other locations)
• Trial ID: NCT06152341 on ClinicalTrials.gov

What this trial studies

This interventional study aims to assess the safety and effectiveness of the ATC System in patients diagnosed with acute pulmonary embolism. It is a prospective, single-arm, multicenter trial that will include participants who exhibit clinical signs of acute PE and meet specific eligibility criteria. The study will monitor outcomes related to the intervention over a defined period to determine its efficacy in managing this critical condition.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 90 who have been diagnosed with acute pulmonary embolism within the last 14 days.

Not a fit: Patients with a history of pulmonary embolism within the last 180 days or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients suffering from acute pulmonary embolism.

How similar studies have performed: While the ATC System is being evaluated in this study, similar approaches in treating acute pulmonary embolism have shown promise in other clinical settings.

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.

Where this trial is running

São Paulo, São Paulo and 3 other locations

• Instituto do Coracao — São Paulo, São Paulo, Brazil (RECRUITING)
• Instituto Dante Pazzanese de Cardiologia — São Paulo, Brazil (RECRUITING)
• Corazones Del Cibao — Santiago de los Caballeros, Santiago Province, Dominican Republic (NOT_YET_RECRUITING)
• Centro de Intervenciones Cardiovasculares — Santiago de los Caballeros, Santiago Province, Dominican Republic (RECRUITING)

Study contacts

• Study coordinator: Rukhsana Khanum

Conditions: Pulmonary Embolism Acute