IMPEDE and IMPEDE-FX Embolization Plug Registry

NCT ID: NCT04044443

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-09

Study Completion Date

2026-09-30

Brief Summary

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EMBO-PMS is a prospective, multicentre, registry study of the IMPEDE and IMPEDE-FX Embolization Plug Systems

Detailed Description

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Conditions

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Peripheral Vascular Embolization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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IMPEDE, IMPEDE-FX or IMPEDE-FX RapidFill

Peripheral vascular embolization

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Study participant is ≥18 years of age
* Study participant is considered a candidate for arterial or venous embolization of the peripheral vasculature

Exclusion Criteria

* Study participant has an inability to provide written informed consent
* Study participant/treatment outside of the approved study device labeling, instructions for use (IFU)
* Study participant is a prisoner or member of other vulnerable population
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shape Memory Medical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Morgan, MBChB

Role: STUDY_CHAIR

St George's Hospital (St George's University Hospitals NHS Foundation Trust)

Götz Richter

Role: STUDY_CHAIR

Klinikum Stuttgart

Locations

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Universitätsklinikum Carl-Gustav-Carus an der Technischen Universität Dresden

Dresden, , Germany

Site Status

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Site Status

Universitätsklinikum Schleswig-Holstein (Campus Kiel)

Kiel, , Germany

Site Status

UNIVERSITÄTSKLINIKUM LEIPZIG AöR

Leipzig, , Germany

Site Status

Klinikum München rechts der Isar

München, , Germany

Site Status

Klinikum Nürnberg

Nuremberg, , Germany

Site Status

Klinikum StuttGart

Stuttgart, , Germany

Site Status

Uniklinikum Würzburg

Würzburg, , Germany

Site Status

St George's Hospital (St George's University Hospitals NHS Foundation Trust)

London, , United Kingdom

Site Status

St Mary's Hospital (Imperial College Healthcare NHS Trust)

London, , United Kingdom

Site Status

Countries

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Germany United Kingdom

Other Identifiers

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CRD1012

Identifier Type: -

Identifier Source: org_study_id