Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
Part of paid clinical trials in El Paso, Texas.
- Sponsor
- Medtronic Endovascular
- Study ID
- NCT07639853
- Status
- Enrolling By Invitation
Conditions
- Arteriovenous Malformation
- Gastric Varices
- Gastrointestinal Bleed
- Hemorrhage
- Hemorrhoid
- Pelvic Venous Disorders
- Peripheral Aneurysms
- Portal Vein Embolization
- Type II Endoleak
- Varicocele
Eligibility Criteria
- Sex
- ALL
- Age
- 22 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Concerto Versa™ Detachable Coils — DEVICEConcerto Versa™ detachable coil is indicated for arterial and venous embolization in the peripheral vasculature
Study Details
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.
Key Dates
- First listed
- Jun 10, 2026
- Start date
- Jul 24, 2026
- Status verified
- Aug 2026
- Primary completion
- Nov 30, 2026
- Completion
- Nov 30, 2026
Study Design
- Enrollment
- 30 participants (estimated)
Arms
- Arm: Adult patients treated with Concerto Versa™ Detachable CoilThe Concerto Versa™ Detachable Coil is indicated for arterial and venous embolization in adult patients requiring embolization in the peripheral vasculature.
Primary Outcome Measure
Rate of peri-procedural adverse events [ Time Frame: During the Index Procedure ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Del Sol Medical Center | El Paso | Texas | 79925 | - |
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