๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-06-30

Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism (NCT04790370)

A Randomized Trial of Ultrasound-facilitated, Catheter-directed, Thrombolysis Versus Anticoagulation for Acute Intermediate-high Risk Pulmonary Embolism: The Higher-risk Pulmonary Embolism Thrombolysis Study

๐Ÿ”ต Active, Not Recruiting Phase4 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Boston Scientific Corporation

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

There are many available treatments for pulmonary embolism (PE), but the best treatment for this condition is not known. The HI-PEITHO study will compare two treatment options that are both available on the market for the treatment of PE. Patients will be randomized 1:1 to receive either blood thinners (anticoagulation) or blood thinners (anticoagulation) in combination with a device called the EkoSonicTM Endovascular device to dissolve blood clots. Patients will be followed for 12 months after randomization and have assessments while in the hospital as well as at 7 days, 30 days, 6 months and 12 months after randomization. The study will try to find out if one of these treatments is better than the other at reducing the risk of death and other serious problems.

Who can join: Review the eligibility criteria below.

Location: University of Alabama at Birmingham โ€” Birmingham, Alabama

Age range: 18 Years to 80 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (60 Sites)

Showing the first 25 of 60 sites.

  • University of Alabama at Birmingham โ€” Birmingham, Alabama
  • Cedars - Sinai Medical Center โ€” Los Angeles, California
  • Christiana Hospital โ€” Newark, Delaware
  • Piedmont Hospital โ€” Atlanta, Georgia
  • Emory University Hospital โ€” Atlanta, Georgia
  • Augusta University โ€” Augusta, Georgia
  • Methodist Hospitals โ€” Merrillville, Indiana
  • Baptist Health East Louisville โ€” Lousville, Kentucky
  • University of Maryland School of Medicine โ€” Baltimore, Maryland
  • Massachusetts General Hospital โ€” Boston, Massachusetts
  • University of Michigan Hospitals โ€” Ann Arbor, Michigan
  • Henry Ford Hospital โ€” Detroit, Michigan
  • North Mississippi Medical Center โ€” Tupelo, Mississippi
  • Nebraska Methodist Hospital โ€” Omaha, Nebraska
  • Dartmouth-Hitchcock Medical Center โ€” Lebanon, New Hampshire
  • Newark Beth Israel Medical Center โ€” Newark, New Jersey
  • Mount Sinai Medical Center โ€” New York, New York
  • Columbia University Medical Center โ€” New York, New York
  • Lenox Hill Hospital โ€” New York, New York
  • University Hospitals of Cleveland โ€” Cleveland, Ohio
  • Kettering Health โ€” Kettering, Ohio
  • Wellmont Holston Valley Medical Center โ€” Kingsport, Tennessee
  • Vanderbilt University Medical Center โ€” Nashville, Tennessee
  • Seton Medical Center โ€” Austin, Texas
  • Houston Methodist Sugarland Hospital โ€” Houston, Texas

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—