An observational study in Arteriovenous Malformation, Gastrointestinal Bleed and Gastric Varices, sponsored by Medtronic Endovascular. Enrolling by invitation at 3 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Medtronic Endovascular (part of Medtronic) · Observational
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.
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.
92 studies on the registry are indexed under Arteriovenous Malformations; 29 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 41 observational studies indexed under Arteriovenous Malformations.
Browse Arteriovenous Malformations studies →Medtronic Endovascular is the lead sponsor of 51 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
The Concerto Versa™ Detachable Coil is indicated for arterial and venous embolization in adult patients requiring embolization in the peripheral vasculature.
Inclusion Criteria:
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
Concerto Versa™ detachable coil is indicated for arterial and venous embolization in the peripheral vasculature
Rate of peri-procedural adverse events
The rate of peri-procedural adverse events related to device and/or procedure.
Time frame: 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.
Time frame: During the Index Procedure
Rate of Peri-procedural success
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.
Time frame: During the Index Procedure
Plan to share: No — No patients will be engaged, and no medical records will be accessed or used. Individual HCP responses for each case will be aggregated into a final report.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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