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The purpose of the Case-Specific Health Care Professional (HCP) Clinical Survey for Concerto Versaâ„¢ 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 Versaâ„¢ 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 Versaâ„¢ 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 Versaâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients treated with Concerto Versaâ„¢ Detachable Coil | The Concerto Versaâ„¢ Detachable Coil is indicated for arterial and venous embolization in adult patients requiring embolization in the peripheral vasculature. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concerto Versaâ„¢ Detachable Coils | Device | Concerto Versaâ„¢ detachable coil is indicated for arterial and venous embolization in the peripheral vasculature |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of peri-procedural adverse events | The rate of peri-procedural adverse events related to device and/or procedure. | 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. | During the Index Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During the Index Procedure |
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Inclusion Criteria:
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The Concerto Versaâ„¢ Detachable Coil is indicated for arterial and venous embolization in adult patients requiring embolization in the peripheral vasculature.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samantha Udondem | Contact | 763-526-2042 | samantha.udondem@medtronic.com | |
| Elizabeth Hunt | Contact | 720-207-4213 | elizabeth.m.hunt@medtronic.com |
| Name | Affiliation | Role |
|---|---|---|
| John R Laird, Jr, MD | Medtronic Endovascular | Principal Investigator |
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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.
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| ID | Term |
|---|---|
| D001165 | Arteriovenous Malformations |
| D006471 | Gastrointestinal Hemorrhage |
| D004932 | Esophageal and Gastric Varices |
| D006484 | Hemorrhoids |
| D014646 | Varicocele |
| D006470 | Hemorrhage |
| D016491 | Peripheral Vascular Diseases |
| D014652 | Vascular Diseases |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004935 | Esophageal Diseases |
| D006975 | Hypertension, Portal |
| D008107 | Liver Diseases |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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