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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Embolism Acute
• Intervention / Treatment: Device: ATC System

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Uday Illindala; Phone Number: +1 408-560-2500; Email: clinicalaffairs@akuramed.com
• Study Contact Backup: Name: Rukhsana Khanum; Phone Number: +1 408-560-2500; Email: clinicalaffairs@akuramed.com

Study Locations

• Brazil
  • Sao Paulo, Brazil, 04012-000
    • Recruiting
    • Instituto Dante Pazzanese de Cardiologia
    • Contact: Patricia Paiva; Email: patricia.paiva@dantepazzanese.org.br
    • Principal Investigator: Fabio Rossi
  • Sao Paulo
    • São Paulo, Sao Paulo, Brazil, 05403-000
      • Recruiting
      • Instituto do Coracao
      • Contact: Katiane Oliveira; Email: katiane.oliveira@incor.usp.br
      • Principal Investigator: Rogerio Rogerio, Souza
• Dominican Republic
  • Santiago
    • Santiago De Los Caballeros, Santiago, Dominican Republic, 51000
      • Not yet recruiting
      • Corazones Del Cibao
      • Contact: Franklyn Colon
      • Contact: Rosa Hawa Fernandez; Email: rosafdezhawa@gmail.com
    • Santiago De Los Caballeros, Santiago, Dominican Republic
      • Recruiting
      • Centro de Intervenciones Cardiovasculares
      • Contact: Andres Marin, Dr.
      • Contact: Rosa Fernandez Hawa; Email: rosafdezhawa@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with Acute Pulmonary Embolism; Patients undergoing mechanical thrombectomy for acute pulmonary embolism.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness	Change in RV/LV ratio	48 hours post index procedure
Safety: Composite of Major Adverse Device-Related Events	Device-related major bleeding at access, device-related death, clinical deterioration, pulmonary vascular injury or cardiac injury	48 hours post index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Composite of Major Adverse Events	Assessment of major adverse events through 30 day follow-up	30 days post index procedure

Collaborators and Investigators

• Sponsor: Akura Medical

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Estimated): August 15, 2025
• Study Completion (Estimated): September 15, 2025

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: November 22, 2023
• First Posted (Actual): November 30, 2023

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Pulmonary Embolism; Embolism
• Other Study ID Numbers: CP-60003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes