Interventional Cardiology - Quadra-PE

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).

Criteria:

Inclusion:

  • 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:

  • Prior PE <180 days from index procedure
  • Vasopressor requirement after fluids to keep pressure at ≥ 90 mmHg
  • Platelets < 100,000/μL
  • 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.

Location: Hartford Hospital

Contact: Vicky Macleod 860-972-5799 Vicky.Macleod@hhchealth.org

Sponsor: Akura Medical