Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils

The purpose of the Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils, also known as the Concerto Versa HCP Clinical Assessment, is to collect early clinical data from HCPs to assess clinical safety and performance of the Concerto Versa™ Detachable Coils, when used in accordance with approved device labeling per the Instructions for Use (IFU). Data collected will generate clinical evidence to quantitatively assess clinical safety and device performance for the purpose of obtaining European Union Medical Device Regulation (EU MDR) approval.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemorrhage; Varicocele; Gastric Varices; Peripheral Aneurysms; Hemorrhoid; Pelvic Venous Disorders; Arteriovenous Malformation; Gastrointestinal Bleed; Portal Vein Embolization; Type II Endoleak
• Intervention / Treatment: Device: Concerto Versa™ Detachable Coils

Detailed Description

The Concerto Versa™ HCP Clinical Assessment is a multicenter, prospective per patient HCP recollection survey. Participating HCPs will document their individual use case experience following routine utilization of Concerto Versa™ in accordance with the approved device labeling. Individual use cases will be entered within 72 hours of device usage to identify periprocedural safety incidents and evaluate device performance. At least 30 use cases will be collected and aggregated from participating HCPs. This data collection is a for a single point in time, with no patient follow-up. Individual HCP responses for each case will be aggregated by a third party vendor.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Samantha Udondem; Phone Number: 763-526-2042; Email: samantha.udondem@medtronic.com
• Study Contact Backup: Name: Elizabeth Hunt; Phone Number: 720-207-4213; Email: elizabeth.m.hunt@medtronic.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The Concerto Versa™ Detachable Coil is indicated for arterial and venous embolization in adult patients requiring embolization in the peripheral vasculature.

Description

Inclusion Criteria:

1. Patient treated with Concerto Versa™ Detachable Coil is age ≥ 22 years at the time of procedure.
2. Use of Concerto Versa™ Detachable Coil in accordance with the device labeling.
3. Reporting of case within 72 hours of index procedure.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult patients treated with Concerto Versa™ Detachable Coil; The Concerto Versa™ Detachable Coil is indicated for arterial and venous embolization in adult patients requiring embolization in the peripheral vasculature.	Device: Concerto Versa™ Detachable Coils; Concerto Versa™ detachable coil is indicated for arterial and venous embolization in the peripheral vasculature

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of peri-procedural adverse events	The rate of peri-procedural adverse events related to device and/or procedure.	Index Procedure
Rate of Technical Success	Technical success is defined as successful delivery and detachment of the coil, and removal of the delivery-pusher.	Index Procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Peri-procedural success	Peri-procedural success is defined as ability of the device to successfully obstruct or reduce the rate of blood flow to the target lesion as determined by physician judgment.	Index Procedure

Collaborators and Investigators

• Sponsor: Medtronic Endovascular
• Investigators: Principal Investigator: John R Laird, Jr, MD, Medtronic Endovascular

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: June 5, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Peripheral Vascular Disease; Vascular Disease; Peripheral Arterial Disease; Embolization; Arterial Embolization; Arteriovenous Embolization; Venous Embolization; Embolization Coils; Peripheral Embolization Coils
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Cardiovascular Diseases; Pathologic Processes; Genital Diseases, Male; Male Urogenital Diseases; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Liver Diseases; Esophageal Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Malformations; Hypertension, Portal; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Peripheral Arterial Disease; Hemorrhage; Peripheral Vascular Diseases; Gastrointestinal Hemorrhage; Hemorrhoids; Arteriovenous Malformations; Esophageal and Gastric Varices; Varicocele
• Other Study ID Numbers: MDT25037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No patients will be engaged, and no medical records will be accessed or used. Individual HCP responses for each case will be aggregated into a final report.

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.: No