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

NCT07639853 — Enrolling by invitation, 30 participants, Medtronic Endovascular

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Registry	NCT07639853
Status	Enrolling by invitation
Study type	Observational
Enrollment	30 (Estimated)
Sponsor	Medtronic Endovascular (Industry)
Conditions	Arteriovenous Malformation, Gastrointestinal Bleed, Gastric Varices, Hemorrhoid, Pelvic Venous Disorders, Peripheral Aneurysms, Portal Vein Embolization, Type II Endoleak, Varicocele, Hemorrhage
Interventions	Concerto Versa™ Detachable Coils (Device)
Dates	start 2026-07-24, primary completion 2026-11-01 (estimated), completion 2026-11-01 (estimated), first posted 2026-06-10, last updated 2026-10-15
Locations	3 sites in United States

-Summary

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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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Adult patients treated with Concerto Versa™ Detachable Coil		Device: Concerto Versa™ Detachable Coils	The Concerto Versa™ Detachable Coil is indicated for arterial and venous embolization in adult patients requiring embolization in the peripheral vasculature.

Concerto Versa™ Detachable Coils (Device): Concerto Versa™ detachable coil is indicated for arterial and venous embolization in the peripheral vasculature

+Outcome measures

Primary outcomes

Rate of peri-procedural adverse events [During the Index Procedure]: The rate of peri-procedural adverse events related to device and/or procedure.
Rate of Technical Success [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 [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.

+Eligibility

Sex: All, ages: 22 Years to any

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.

+Locations (3)

Facility	City	Country
Rutgers University	Piscataway, New Jersey	United States
The Mount Sinai Hospital	New York, New York	United States
Del Sol Medical Center	El Paso, Texas	United States

+Investigators

John R Laird, Jr, MD, Principal investigator, Medtronic Endovascular