An Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres

Terumo Medical Corporation99 enrolled

Overview

This registry study is designed to collect data on the procedural success and complication rates in real-world patients undergoing HydroPearl embolization procedures via radial access.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Uterine Fibroid Arteriovenous Malformations Hypervascular Tumors Benign Prostatic Hyperplasia

Interventions

Treatment with HydroPearl via radial accessDEVICE

This is an observational study collecting data on patients who are already being treated with HydroPearl on-label per standard of care.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject is ≥ 18 years old 2. Subject is scheduled for a procedure for treatment with HydroPearl microspheres using radial access. 3. Subject is willing and able to complete follow-up requirements 4. Subject is willing and able to sign a written Informed Consent form prior to participating in the registry. Exclusion Criteria: 1. Unable to have a procedure with radial access for any reason. 2. Participating in another clinical study which, in the opinion of the investigator, could impact the results of this registry. 3. Pregnant or planning to become pregnant during the study.

Locations (6)

University of California - Los Angeles

Los Angeles, California, United States

Rush University Medical Center

Chicago, Illinois, United States

SLU Department of Radiology

St Louis, Missouri, United States

Mount Sinai

New York, New York, United States

Outcomes

Primary Outcomes

Procedural Success

Defined as completing the planned procedure without femoral access bailout

Time frame: Duration of procedure (measured from the time the participant is sedated (start of study procedure) until all products are removed from the participant and closure is confirmed (end of the intended study procedure))

Technical Success

Delivery of HydroPearls to the target vessel and slowing the blood flow with microsphere embolization

Time frame: Duration of procedure (from when the injection of HydroPearls is started until access site closure has been completed)

Freedom From Major Adverse Events and Radial Access Complications

Major Adverse Events are defined as the following: Death MI Stroke

Time frame: within 30 days post-procedure

Radial Access Related Complications Within 30 Days

Radial access related complications that occurred within 30 days of the index procedure include, but are not limited to, the following: Radial Artery Occlusion (RAO) Hand Ischemia Arteriovenous Fistula Pseudoaneurysm Any complication requiring surgical and/or endovascular intervention within 30 days of the index procedure

Time frame: 30 days post procedure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.