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

NCT06152341 | Recruiting FDA Device

• 1 other identifier: CP-60003
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 4

Brief Summary

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).

Conditions

Pulmonary Embolism Acute

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Safety: Composite of Major Adverse Events

  30 days post index procedure

Study Arms (1)

Patients with Acute Pulmonary Embolism

EXPERIMENTAL

Patients undergoing mechanical thrombectomy for acute pulmonary embolism.

Device: ATC System

Interventions

ATC System DEVICE

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

Patients with Acute Pulmonary Embolism

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akura Medical: lead

Study Sites (4)

Instituto do Coracao

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Instituto Dante Pazzanese de Cardiologia

São Paulo, 04012-000, Brazil

RECRUITING

Corazones Del Cibao

Santiago de los Caballeros, Santiago Province, 51000, Dominican Republic

NOT YET RECRUITING

Centro de Intervenciones Cardiovasculares

Santiago de los Caballeros, Santiago Province, Dominican Republic

RECRUITING

Central Study Contacts

Rukhsana Khanum

CONTACT

+1 408-560-2500; clinicalaffairs@akuramed.com

Uday Illindala

CONTACT

+1 408-560-2500; clinicalaffairs@akuramed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: November 30, 2023
• Study Start: May 15, 2024
• Primary Completion: August 15, 2025
• Study Completion: September 15, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DO (2); BR (2)