Interventional Cardiology - SPIRARE II
The study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vertex Pulmonary Embolectomy System in patients presenting with clinical signs and symptoms of acute pulmonary embolism. The system treats acute pulmonary embolism through mechanical aspiration thrombectomy.
Criteria:
Key Inclusion:
- Acute onset of symptoms ≤ 14 days consistent with the presence of pulmonary embolism.
- CTA evidence of proximal PE
Key Exclusion:
- Known bleeding or clotting disorder
- Thrombolytic use within 30 days of baseline CTA
- Pulmonary hypertension with peak pulmonary artery pressure > 70 mmHg by right heart catheterization
- Decompensated heart failure
Location: Hartford Hospital
Sponsor: Neptune Medical/Jupiter Endovascular
Contact: Vicky Macleod Vicky.Macleod@hhchealth.org 860-972-5799