An Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres

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.

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Key information

Conditions

Uterine Fibroid Arteriovenous Malformations Benign Prostatic Hyperplasia Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genital Diseases Genital Diseases, Male Hypervascular Tumors Leiomyoma Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases Vascular Diseases Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California - Los Angeles, Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject is ≥ 18 years old
Subject is scheduled for a procedure for treatment with HydroPearl microspheres using radial access.
Subject is willing and able to complete follow-up requirements
Subject is willing and able to sign a written Informed Consent form prior to participating in the registry.

Exclusion criteria

Unable to have a procedure with radial access for any reason.
Participating in another clinical study which, in the opinion of the investigator, could impact the results of this registry.
Pregnant or planning to become pregnant during the study.

Treatment and study plan

Treatment with HydroPearl via radial access

Device

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

Primary outcomes

Procedural Success

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))

Defined as completing the planned procedure without femoral access bailout
Technical Success

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

Delivery of HydroPearls to the target vessel and slowing the blood flow with microsphere embolization
Freedom From Major Adverse Events and Radial Access Complications

Time frame: within 30 days post-procedure

Major Adverse Events are defined as the following:

Death MI Stroke
Radial Access Related Complications Within 30 Days

Time frame: 30 days post procedure

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

Sponsors and collaborators

Lead sponsor

Terumo Medical Corporation

Industry

Registry information

Official study title

The RAVI Registry: A Prospective, Multi-Center, Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres

Acronym: RAVI Registry

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2023
First posted: Feb 17, 2020
Registry last updated: Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed