IMPEDE and IMPEDE-FX Embolization Plug Registry

Recruiting

• Conditions: Peripheral Vascular Embolization

• Registration Number: NCT04044443
• Lead Sponsor: Shape Memory Medical, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-09
• Study First Submitted: 2019-07-31
• Study First Submitted QC: 2019-08-01
• Study First Posted: 2019-08-05
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-13
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety - Rate of freedom from serious adverse events	30 days	Rate of freedom from serious adverse events related to the study devices and/or procedure, per review and adjudication by medical monitor
Efficacy - Rate of technical success (embolization of target vessel)	Immediately after the intervention	Technical success, defined as embolization of the target area after deployment of the study device

Secondary Outcome Measures

Name	Time	Method
Efficacy - Rate of treated vessel occlusion	90 days	Treated vessel occlusion, measured per study site standard of care for the original condition treated
Safety - Rate of freedom from serious adverse events	90 days	Rate of freedom from serious adverse events related to the study devices and/or procedure, per review and adjudication by medical monitor
Efficacy - Rate of recurrence of clinical symptoms, based on original complaint	90 days	Number of participants free of recurrent clinical symptoms, based on clinical symptoms of original complaint

Trial Locations

Locations (10)

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Klinikum Nürnberg; 🇩🇪 Nürnberg, Germany

Universitätsklinikum Carl-Gustav-Carus an der Technischen Universität Dresden; 🇩🇪 Dresden, Germany

Klinikum München rechts der Isar; 🇩🇪 München, Germany

Uniklinikum Würzburg; 🇩🇪 Würzburg, Germany

Universitätsklinikum Schleswig-Holstein (Campus Kiel); 🇩🇪 Kiel, Germany

UNIVERSITÄTSKLINIKUM LEIPZIG AöR; 🇩🇪 Leipzig, Germany

St George's Hospital (St George's University Hospitals NHS Foundation Trust); 🇬🇧 London, United Kingdom

St Mary's Hospital (Imperial College Healthcare NHS Trust); 🇬🇧 London, United Kingdom

Klinikum StuttGart; 🇩🇪 Stuttgart, Germany