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

Official title

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

Overview

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).

Interventions

• Device ATC System
  The ATC System is designed to mechanically remove emboli and restore blood flow through the pulmonary arteries in patients experiencing acute PE

Primary outcome measures

• Effectiveness [Time frame: 48 hours post index procedure]
• Safety: Composite of Major Adverse Device-Related Events [Time frame: 48 hours post index procedure]

Secondary outcome measures (1)

• Safety: Composite of Major Adverse Events [Time frame: 30 days post index procedure]

Eligibility criteria

Inclusion criteria

• Patient is ≥ 18 and ≤ 90 years old
• Clinical signs and symptoms consistent with acute PE for < 14 days
• CTA evidence of proximal PE
• RV/LV ratio > 0.9
• Systolic BP ≥90 mmHg without the need for vasopressors
• Stable heart rate (HR) < 130 BPM prior to procedure
• Patient is deemed medically eligible for interventional procedure(s), per investigator guidelines and clinical judgment
• 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

• Prior PE < 180 days from index procedure
• Thrombolytic use < 30 days prior to baseline CTA
• Pulmonary hypertension with peak pulmonary artery systolic pressure (PASP) >70 mmHg by right heart catheterization
• FiO2 requirement >40% or >6 LPM to keep oxygen saturation >90%
• Hematocrit <28%
• Platelets count <100,000/µL
• Serum creatinine >1.8 mg/dL
• International normalized ratio (INR) >3
• Major trauma injury severity score (ISS) >15 prior to screening assessment
• Presence of intracardiac lead in right ventricle or atrium placed within 6 months prior to screening assessment
• Cardiovascular or pulmonary surgery within 7 days of index procedure
• 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 decompensated heart failure
• History of underlying lung disease that is oxygen dependent
• History of chest irradiation
• History of heparin-induced thrombocytopenia (HIT)
• Contraindication to systemic or therapeutic doses of anticoagulants
• Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
• Imaging evidence or other evidence that suggest, in the opinion of the investigator, the Subject is not appropriate for aspiration thrombectomy intervention
• Life expectancy <90 days, as determined by investigator such as stage 4 cancer, frailty or severe COVID infections
• Female who is pregnant or nursing
• Current participation in another investigational drug or device treatment study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Brazil · 2 centers

• Instituto do Coracao — São Paulo
• Instituto Dante Pazzanese de Cardiologia — São Paulo

Dominican Republic · 2 centers

• Corazones Del Cibao — Santiago de los Caballeros
• Centro de Intervenciones Cardiovasculares — Santiago de los Caballeros

Identifiers

NCT: NCT06152341 · CP-60003

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗