An Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres (RAVI Registry)

The RAVI Registry: A Prospective, Multi-Center, 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.

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia; Arteriovenous Malformations; Uterine Fibroid; Hypervascular Tumors
• Intervention / Treatment: Device: Treatment with HydroPearl via radial access

• Study Type: Observational
• Enrollment (Actual): 99

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California - Los Angeles
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • SLU Department of Radiology
  • New York
    • New York, New York, United States, 11766
      • Mount Sinai
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This is a prospective, multi-center, registry study to assess the procedural success, technical success, and complication rate of radial access procedures using HydroPearl microspheres.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment with HydroPearl via radial access; all patients will be in the same group/cohort in this open-label, single-arm, observational registry.	Device: Treatment with HydroPearl via radial access; This is an observational study collecting data on patients who are already being treated with HydroPearl on-label per standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Success	defined as completing the planned procedure without femoral access bailout	During procedure
Technical Success	delivery of HydroPearl to the target vessel and slowing the blood flow with microsphere embolization	End of procedure
Freedom from major adverse events and radial access complications		within 30 days post-procedure

Collaborators and Investigators

• Sponsor: Terumo Medical Corporation
• Investigators: Principal Investigator: Marcelo Guimaraes, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2020
• Primary Completion (Actual): March 7, 2022
• Study Completion (Actual): March 11, 2023

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: February 14, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Congenital Abnormalities; Prostatic Diseases; Cardiovascular Abnormalities; Vascular Malformations; Neoplasms, Muscle Tissue; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Hyperplasia; Hyperplasia; Arteriovenous Malformations; Leiomyoma
• Other Study ID Numbers: TIS2019-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes