Peripheral Vascular EmbolizationEMBO-PMSNCT04044443
IMPEDE and IMPEDE-FX Embolization Plug Registry
An observational study of Peripheral Vascular Embolization, run by Shape Memory Medical, Inc. at 10 sites in 2 countries.
Trial summary
EMBO-PMS is a prospective, multicentre, registry study of the IMPEDE and IMPEDE-FX Embolization Plug Systems Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Embolization
- What is being tested?
- IMPEDE, IMPEDE-FX or IMPEDE-FX RapidFill
- Type of treatment
- Medical device
- How many people
- 108 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 9 Jul 2019to Sep 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult study participants considered candidates for a peripheral vascular embolization procedure
Who may be able to join
- Study participant is ≥18 years of age
- Study participant is considered a candidate for arterial or venous embolization of the peripheral vasculature
Who cannot join
- 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
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Germany8 sites
Universitätsklinikum Carl-Gustav-Carus an der Technischen Universität Dresden
Dresden, 01307
Universitätsklinikum Heidelberg
Heidelberg, 69120
Universitätsklinikum Schleswig-Holstein (Campus Kiel)
Kiel, 24105
UNIVERSITÄTSKLINIKUM LEIPZIG AöR
Leipzig, 04103
Klinikum München rechts der Isar
München, 81675
Klinikum Nürnberg
Nuremberg, 90471
Klinikum StuttGart
Stuttgart, 70174
Uniklinikum Würzburg
Würzburg, 97080
United Kingdom2 sites
St George's Hospital (St George's University Hospitals NHS Foundation Trust)
London
St Mary's Hospital (Imperial College Healthcare NHS Trust)
London
About this study
Official title: Post Market Registry of the IMPEDE and IMPEDE-FX Embolization Plugs
EMBO-PMS is a prospective, multicentre, registry study of the IMPEDE and IMPEDE-FX Embolization Plug Systems
- Conditions
- Peripheral Vascular Embolization
- Being tested
- IMPEDE, IMPEDE-FX or IMPEDE-FX RapidFill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMPEDE, IMPEDE-FX or IMPEDE-FX RapidFillDevice
Peripheral vascular embolization
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Rate of freedom from serious adverse events
Rate of freedom from serious adverse events related to the study devices and/or procedure, per review and adjudication by medical monitor
Measured: 30 days
Efficacy - Rate of technical success (embolization of target vessel)
Technical success, defined as embolization of the target area after deployment of the study device
Measured: Immediately after the intervention
Secondary outcomes (3)
Efficacy - Rate of recurrence of clinical symptoms, based on original complaint
Number of participants free of recurrent clinical symptoms, based on clinical symptoms of original complaint
Measured: 90 days
Efficacy - Rate of treated vessel occlusion
Treated vessel occlusion, measured per study site standard of care for the original condition treated
Measured: 90 days
Safety - Rate of freedom from serious adverse events
Rate of freedom from serious adverse events related to the study devices and/or procedure, per review and adjudication by medical monitor
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start9 Jul 2019
- Primary completion30 Aug 2025
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular EmbolizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shape Memory Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Morgan, MBChB, Study chair, St George's Hospital (St George's University Hospitals NHS Foundation Trust)Götz Richter, Study chair, Klinikum Stuttgart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044443
- Sponsor's protocol ID
- CRD1012
- Acronym
- EMBO-PMS
- Status last verified
- Dec 2025
- First submitted
- 31 Jul 2019
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Registry of the IMPEDE and IMPEDE-FX Embolization Plugs
- ClinicalTrials.gov ID
- NCT04044443
- Acronym / sponsor ID
- EMBO-PMS / CRD1012
- Conditions
- Peripheral Vascular Embolization
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Shape Memory Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
EMBO-PMS is a prospective, multicentre, registry study of the IMPEDE and IMPEDE-FX Embolization Plug Systems
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult study participants considered candidates for a peripheral vascular embolization procedure
Key inclusion criteria (2 listed)
- Study participant is ≥18 years of age
- Study participant is considered a candidate for arterial or venous embolization of the peripheral vasculature
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMPEDE, IMPEDE-FX or IMPEDE-FX RapidFillPeripheral vascular embolization | Device | – |
Primary outcome
Safety - Rate of freedom from serious adverse events
Time frame: 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)
Time frame: Immediately after the intervention
Technical success, defined as embolization of the target area after deployment of the study device
3 secondary outcomes
Efficacy - Rate of recurrence of clinical symptoms, based on original complaint
Time frame: 90 days
Efficacy - Rate of treated vessel occlusion
Time frame: 90 days
Safety - Rate of freedom from serious adverse events
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Morgan, MBChB study chair
St George's Hospital (St George's University Hospitals NHS Foundation Trust)
Götz Richter study chair
Klinikum Stuttgart
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Vascular Embolization, run by Shape Memory Medical, Inc. at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Rate of freedom from serious adverse events (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.