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

The purpose of the Case-Specific Health Care Professional (HCP) 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.

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Key information

Conditions

Arteriovenous Malformation Arterial Occlusive Diseases Arteriosclerosis Arteriovenous Malformations Atherosclerosis Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Esophageal Diseases Esophageal and Gastric Varices Gastric Varices Gastrointestinal Bleed Gastrointestinal Diseases Gastrointestinal Hemorrhage Genital Diseases Genital Diseases, Male Hemorrhage Hemorrhoid Hemorrhoids Hypertension, Portal Intestinal Diseases Liver Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Venous Disorders Peripheral Aneurysms Peripheral Arterial Disease Peripheral Vascular Diseases Portal Vein Embolization Rectal Diseases Type II Endoleak Urogenital Diseases Varicocele Vascular Diseases Vascular Malformations

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

The Concerto Versa™ Health Care Professional (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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Treatment and study plan

Concerto Versa™ Detachable Coils

Device

Concerto Versa™ detachable coil is indicated for arterial and venous embolization in the peripheral vasculature

Primary outcomes

Rate of peri-procedural adverse events

Time frame: During the Index Procedure

The rate of peri-procedural adverse events related to device and/or procedure.
Rate of Technical Success

Time frame: During the Index Procedure

Technical success is defined as successful delivery and detachment of the coil, and removal of the delivery-pusher.

Secondary outcomes

Rate of Peri-procedural success

Time frame: During the Index Procedure

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Hunt

CONTACT

[email protected]

720-207-4213

Samantha Udondem

CONTACT

[email protected]

763-526-2042

Sponsors and collaborators

Lead sponsor

Medtronic Endovascular

Industry

Registry information

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jun 10, 2026
Registry last updated: Jun 15, 2026

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.

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