Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Rate of peri-procedural adverse events
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Concerto Versa™ Detachable Coils (Device)
Outcomes
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(During the Index Procedure)