NCT06672510

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jan 2025Dec 2026

First Submitted

Initial submission to the registry

November 1, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

1.9 years

First QC Date

November 1, 2024

Last Update Submit

December 11, 2025

Conditions

Pulmonary Embolism Acute

Outcome Measures

Primary Outcomes (2)

  • Effectiveness

    Change in RV/LV ratio from baseline

    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

Interventions

ATCDEVICE

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

Patients with Acute Pulmonary Embolism

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient is 18 years of age or older and deemed medically eligible for interventional procedure, per institutional guidelines and clinical judgement
  • Clinical signs, symptoms and presentation 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)
  • CTA evidence of RV/LV ratio of ≥ 0.9 (NOTE: Enrollment qualification assessment is based on the Investigator's interpretation of RV/LV ratio at baseline)
  • Systolic BP ≥ 90 mmHg (initial SBP may be \< 90 mmHg but ≥ 80 mmHg if the pressure recovers with volume resuscitation)
  • Stable HR \< 130 BPM prior to the procedure

You may not qualify if:

  • Prior PE \<180 days from index procedure
  • Thrombolytic use within 30 days prior to baseline CTA
  • Pulmonary hypertension with peak pulmonary arterial pressure (PAP) \> 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 \< 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 ≤ 6 months of enrollment
  • Cardiovascular or pulmonary surgery within the last 7 days
  • Actively progressing cancer treated by chemotherapeutics
  • Known bleeding diathesis or coagulation disorder
  • Left bundle branch block
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Los Robles Regional Medical Center

Thousand Oaks, California, 91360, United States

RECRUITING

Advanced Heart & Vein (ClinRe-001-001)

Thornton, Colorado, 80023, United States

RECRUITING

Hartford Healthcare

Hartford, Connecticut, 06102, United States

RECRUITING

Manatee Hospital / Nova Clinical Research Center

Bradenton, Florida, 32808, United States

ACTIVE NOT RECRUITING

Jacksonville Memorial (HCA)

Jacksonville, Florida, 32216, United States

ACTIVE NOT RECRUITING

Tallahasse Memorial Hospital

Tallahassee, Florida, 32308, United States

RECRUITING

Centracare Heart & Vascular Center

Saint Cloud, Minnesota, 56301, United States

RECRUITING

Columbia University Medical Center

New York, New York, 10032, United States

NOT YET RECRUITING

Cumc/Nyph

New York, New York, 10032, United States

NOT YET RECRUITING

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

RECRUITING

Tristar Centennial Medical Center

Nashville, Tennessee, 37203, United States

RECRUITING

Methodist San Antonio (HCA)

San Antonio, Texas, 78229, United States

RECRUITING

Central Study Contacts

Rukhsana Khanum

CONTACT

4085602500clinicalaffairs@akuramed.com

Uday Illindala

CONTACT

4085602500clinicalaffairs@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 1, 2024

First Posted

November 4, 2024

Study Start

January 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 17, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(12)