Safety and Effectiveness of the Akura Thrombectomy System in the Treatment of Acute Pulmonary Embolism

NCT06362928 | Withdrawn FDA Device

• 1 other identifier: CP-60005
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, single-arm, non-randomized, interventional, multicenter feasibility study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy System in subjects with acute pulmonary embolism (PE).

Conditions

Pulmonary Embolism Acute

Outcome Measures

Primary Outcomes (2)

• Effectiveness

  Change in RV/LV ratio post index procedure

  48 hours

• 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
• PE symptom duration ≤ 14 days
• CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery as determined by the investigator)
• CTA evidence of RV/LV ratio \> 0.9 note: based on Investigator's interpretation of RV/LV ratio at baseline;
• Systolic BP ≥ 90 mmHg note: initial SBP may be \< 90 mmHg but ≥ 80 mmHg if the pressure recovers with volume resuscitation
• 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 \< 48 hours prior to baseline CTA
• Pulmonary hypertension with peak pulmonary artery systolic pressure (PASP) \>70 mmHg by right heart catheterization
• Vasopressor requirement after fluids to keep pressure at ≥90 mmHg
• FiO2 requirement \>40% or \>6 LPM to keep oxygen saturation \>90%
• Hematocrit \<28% (Note: hematocrit required within 6 hrs. of index procedure)
• Platelets count \<100,000/µL
• eGFR \<30 ml/min per 1.73 m2
• International normalized ratio (INR) \>3
• Major trauma injury severity score (ISS) \> 15
• 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

Sponsors & Collaborators

• Akura Medical: lead

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: April 9, 2024
• First Posted: April 12, 2024
• Study Start: February 11, 2025
• Primary Completion: June 17, 2026
• Study Completion: June 17, 2026
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)