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 — DEVICE
    Concerto 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 Coil
    The 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)

FacilityCityStateZIPSite coordinators
Del Sol Medical CenterEl PasoTexas79925-

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