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

A

Akura Medical

Status

Enrolling

Conditions

Pulmonary Embolism Acute

Treatments

Device: ATC System

Study type

Interventional

Funder types

Industry

Identifiers

NCT06152341
CP-60003

Details and patient eligibility

About

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).

Enrollment

30 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Patients with Acute Pulmonary Embolism
Experimental group
Description:
Patients undergoing mechanical thrombectomy for acute pulmonary embolism.
Treatment:
Device: ATC System

Trial contacts and locations

4

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Central trial contact

Bryan Wylie; Uday Illindala

Data sourced from clinicaltrials.gov

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