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

NCT07639853 | Not Yet Recruiting FDA Device

• 1 other identifier: MDT25037
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Arteriovenous Malformation; Gastrointestinal Bleed; Gastric Varices; Hemorrhoid; Portal Vein Embolization; Type II Endoleak; Varicocele; Hemorrhage; Pelvic Venous Disorders; Peripheral Aneurysms

Keywords

Peripheral Vascular Disease; Vascular Disease; Arterial Embolization; Arteriovenous Embolization; Venous Embolization; Embolization Coils; Peripheral Embolization Coils; Peripheral Arterial Disease; Embolization

Outcome Measures

Primary Outcomes (2)

• Rate of peri-procedural adverse events

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

  During the Index Procedure

• Rate of Technical Success

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

  During the Index Procedure

Secondary Outcomes (1)

• Rate of Peri-procedural success

  During the Index Procedure

Study Arms (1)

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

Interventions

Concerto Versa™ Detachable Coils DEVICE

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

Adult patients treated with Concerto Versa™ Detachable Coil

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Endovascular: lead

MeSH Terms

Conditions

Arteriovenous Malformations; Gastrointestinal Hemorrhage; Esophageal and Gastric Varices; Hemorrhoids; Varicocele; Hemorrhage; Peripheral Vascular Diseases; Vascular Diseases; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Hypertension, Portal; Liver Diseases; Rectal Diseases; Intestinal Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• John R Laird, Jr, MD

  Medtronic Endovascular

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha Udondem

CONTACT

763-526-2042; samantha.udondem@medtronic.com

Elizabeth Hunt

CONTACT

720-207-4213; elizabeth.m.hunt@medtronic.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share