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Not yet recruiting NCT07687472

Post-Market Clinical Follow-up Study of i-ED Coil and EDG v4 for Arteriovenous Malformation

No phase Interventional Arteriovenous Malformation (AVM)

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: Endovascular Coil Embolization.
Who it may be relevant to
Registry conditions: Arteriovenous Malformation (AVM). Basic parameters: 18 years — 79 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 →

Official title

Safety and Efficacy of i-ED Coil and EDG v4 for Arteriovenous Malformation - A Prospective Study

Overview

This is a prospective, multicenter, post-market clinical follow-up (PMCF) study to collect safety and performance data in patients with arteriovenous malformations (AVMs) who undergo endovascular coil embolization using the i-ED Coil and Electro Detach Generator v4 (EDG v4).

Interventions

  • Device Endovascular Coil Embolization
    Endovascular embolization performed using the i-ED Coil, a detachable platinum coil system, in combination with the Electro Detach Generator v4 (EDG v4).

Primary outcome measures

  • Post-procedural AVM Occlusion Assessed by Angiography or MRI [Time frame: 12, 36, 60 months]
  • Successful Coil Embolization Assessed by Angiography [Time frame: 12, 36, 60 months]
  • The Frequency of Detachment of Coils During Treatment Procedure [Time frame: Periprocedural]

Eligibility criteria

Inclusion criteria

  • Subjects aged 18 to <80 years
  • Subjects requiring endovascular treatment using coils for arteriovenous malformation
  • Free and informed consent to participate in the investigation obtained from the subject or an acceptable subject representative

Exclusion criteria

  • Coiling or stenting performed on the non-target lesion within 30 days prior to treatment of the target lesion
  • Hunt and Hess score of 3 or higher or modified Rankin Score (mRS) of 4 or higher
  • Subjects with contraindications to CT or MRI procedures
  • Subjects with contraindications to angiography procedures
  • Pregnant or breastfeeding subjects

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07687472 · IED-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗