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NCT06152341 | RECRUITING | Pulmonary Embolism Acute

Safety and Effectiveness of the ATC System in the Treatment of Acute PE
Sponsor:

Adult Medical

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).

Condition or disease

Pulmonary Embolism Acute

Intervention/treatment

ATC System

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Safety and Effectiveness of the ATC System in the Treatment of Acute Pulmonary Embolism
Actual Study Start Date : 2024-05-15
Estimated Primary Completion Date : 2025-04-15
Estimated Study Completion Date : 2025-05-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 90 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Safety and Effectiveness of the ATC System in the Treatment of Acute PE

Location Details

NCT06152341

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Brazil, São Paulo

CORCACATION INSTITUTE

São Paulo, São Paulo, Brazil, 05403-000

RECRUITING

Brazil,

Instituto Dante Pazzanese of Cardiology

São Paulo, Brazil, 04012-000

NOT YET RECRUITING

Dominican Republic, Santiago

Cibao hearts

Santiago de los Caballeros, Santiago, Dominican Republic, 51000

RECRUITING

Dominican Republic, Santiago

Cardiovascular Interventions Center

Santiago de los Caballeros, Santiago, Dominican Republic,