A Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device For the Treatment of Pulmonary Embolism (ENGULF)

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Evaluation of initial safety and clinical feasibility of the Hēlo PE Thrombectomy System for thrombectomy in acute submassive pulmonary embolism (PE).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

⁃ Patients must meet ALL of the following criteria to be eligible for participation in the study:

• \*Patient is \> 18 and \< 90 years old

• \*Clinical signs and symptoms consistent with acute submassive PE with duration ≤ 14 days, as determined by the Investigator

• (\*)CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)

• (\*)RV/LV ratio of ≥ 0.9 (Enrollment qualification assessment based on Investigator's interpretation of RV/LV ratio at baseline)

• \*Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids)

• \*Heart rate \< 130 BPM prior to procedure

• \*Patient is deemed medically eligible for interventional procedure(s), per investigator guidelines and clinical judgment

• Patient signs a written Informed Consent form to participate in the study, prior to any study mandated procedures

Locations
United States
California
Huntington Hospital
RECRUITING
Pasadena
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
RECRUITING
Torrance
Torrance Memorial Medical Center
RECRUITING
Torrance
Florida
Delray Medical Center
RECRUITING
Delray Beach
Baptist Health Research Institute
RECRUITING
Jacksonville
HCA Florida Memorial Hospital
RECRUITING
Jacksonville
Georgia
Northside Hospital
RECRUITING
Atlanta
Piedmont Heart
RECRUITING
Atlanta
Indiana
Indiana University
RECRUITING
Indianapolis
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Brigham and Women's Hospital
RECRUITING
Boston
Ohio
TriHealth Hatton Research Institute
RECRUITING
Cincinnati
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Tennessee
Wellmont Cardiology Services / Ballad Health
COMPLETED
Kingsport
Tennova Healthcare - Turkey Creek Medical Center
RECRUITING
Knoxville
Texas
Austin Heart
RECRUITING
Austin
Baylor Scott & White Research Institute
RECRUITING
Dallas
UT Health
RECRUITING
Houston
Wisconsin
Gundersen Health
RECRUITING
La Crosse
Contact Information
Primary
Patricia Chu
pchu@endovascularengineering.com
3103089089
Backup
Debra Cogan
dcogan@endovascularengineering.com
4085150820
Time Frame
Start Date: 2023-01-12
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 181
Treatments
Experimental: Investigational Device
The study design includes two cohorts: a Pre-Pivotal Cohort of up to 50 subjects (25 Feasibility and up to 25 Roll-Ins), and a Pivotal Cohort enrolling up to 131 subjects, to yield 100 evaluable subjects at 48 hours post procedure.
Related Therapeutic Areas
Sponsors
Leads: Endovascular Engineering

This content was sourced from clinicaltrials.gov