Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Concerto Versa™ Detachable Coils.
- Who it may be relevant to
- Registry conditions: Arteriovenous Malformation, Gastrointestinal Bleed, Gastric Varices, Hemorrhoid. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Device Concerto Versa™ Detachable Coils
Concerto Versa™ detachable coil is indicated for arterial and venous embolization in the peripheral vasculature
Primary outcome measures
- Rate of peri-procedural adverse events [Time frame: During the Index Procedure]
- Rate of Technical Success [Time frame: During the Index Procedure]
Secondary outcome measures (1)
- Rate of Peri-procedural success [Time frame: During the Index Procedure]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07639853 · MDT25037