Arteriovenous Malformation, Gastric Varices, Gastrointestinal Bleed, Hemorrhage, Hemorrhoid, Pelvic Venous Disorders, Peripheral Aneurysms, Portal Vein Embolization, Type II Endoleak, Varicocele
Conditions
Keywords
Peripheral Vascular Disease, Vascular Disease, Arterial Embolization, Arteriovenous Embolization, Venous Embolization, Embolization Coils, Peripheral Embolization Coils, Peripheral Arterial Disease, Embolization
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.
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.
Interventions
DEVICEConcerto Versa™ Detachable Coils
Concerto Versa™ detachable coil is indicated for arterial and venous embolization in the peripheral vasculature
Sponsors
Medtronic Endovascular
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJohn R Laird, Jr, MD
Medtronic Endovascular
Outcome results
None listed