Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
NCT07639853 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 30
Last updated 2026-08-11
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
- Pelvic Venous Disorders
- Peripheral Aneurysms
- Portal Vein Embolization
- Type II Endoleak
- Varicocele
- Hemorrhage
Interventions
- DEVICE
-
Concerto Versa™ Detachable Coils
Concerto Versa™ detachable coil is indicated for arterial and venous embolization in the peripheral vasculature
Sponsors & Collaborators
-
Medtronic Endovascular
lead INDUSTRY
Principal Investigators
-
John R Laird, Jr, MD · Medtronic Endovascular
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-24
- Primary Completion
- 2026-11-30
- Completion
- 2026-11-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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