Arteriovenous MalformationNCT07639853
Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
An observational study of Arteriovenous Malformation and Gastrointestinal Bleed, run by Medtronic Endovascular at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Arteriovenous Malformation, Gastrointestinal Bleed, Gastric Varices
- What is being tested?
- Concerto Versa™ Detachable Coils
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Jul 2026to Nov 2026
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The Concerto Versa™ Detachable Coil is indicated for arterial and venous embolization in adult patients requiring embolization in the peripheral vasculature.
Who may be able to join
- Patient treated with Concerto Versa™ Detachable Coil is age ≥ 22 years at the time of procedure.
- Use of Concerto Versa™ Detachable Coil in accordance with the device labeling.
- Reporting of case within 72 hours of index procedure.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Del Sol Medical Center
El Paso, Texas, 79925
The Mount Sinai Hospital
New York, New York, 10029
Rutgers University
Piscataway, New Jersey, 08854
About this study
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.
Read the detailed description
The Concerto Versa™ Health Care Professional (HCP) Clinical Assessment is a multicenter, prospective per patient HCP recollection survey. Participating HCPs will document their individual use case experience following routine utilization of Concerto Versa™ in accordance with the approved device labeling. Individual use cases will be entered within 72 hours of device usage to identify periprocedural safety incidents and evaluate device performance. At least 30 use cases will be collected and aggregated from participating HCPs. This data collection is a for a single point in time, with no patient follow-up. Individual HCP responses for each case will be aggregated by a third party vendor.
- Conditions
- Arteriovenous Malformation, Gastrointestinal Bleed, Gastric Varices, Hemorrhoid, Pelvic Venous Disorders, Peripheral Aneurysms
- Being tested
- Concerto Versa™ Detachable Coils
- Keywords
- Peripheral Vascular Disease, Vascular Disease, Arterial Embolization, Arteriovenous Embolization, Venous Embolization, Embolization Coils, Peripheral Embolization Coils, Peripheral Arterial Disease, Embolization
- Medical subject headings
- Arteriovenous Malformations, Gastrointestinal Hemorrhage, Esophageal and Gastric Varices, Hemorrhoids, Varicocele, Hemorrhage, Peripheral Vascular Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concerto Versa™ Detachable CoilsDevice
Concerto Versa™ detachable coil is indicated for arterial and venous embolization in the peripheral vasculature
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Concerto Versa™ Detachable Coils |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of peri-procedural adverse events
The rate of peri-procedural adverse events related to device and/or procedure.
Measured: During the Index Procedure
Rate of Technical Success
Technical success is defined as successful delivery and detachment of the coil, and removal of the delivery-pusher.
Measured: During the Index Procedure
Secondary outcomes (1)
Rate of Peri-procedural success
Peri-procedural success is defined as ability of the device to successfully obstruct or reduce the rate of blood flow to the target lesion as determined by physician judgment.
Measured: During the Index Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start24 Jul 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous MalformationStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John R Laird, Jr, MD, Principal investigator, Medtronic Endovascular
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639853
- Sponsor's protocol ID
- MDT25037
- Status last verified
- Oct 2026
- First submitted
- 5 Jun 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No patients will be engaged, and no medical records will be accessed or used. Individual HCP responses for each case will be aggregated into a final report.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
- ClinicalTrials.gov ID
- NCT07639853
- Acronym / sponsor ID
- MDT25037
- Conditions
- Arteriovenous Malformation, Gastrointestinal Bleed, Gastric Varices, Hemorrhoid, Pelvic Venous Disorders, Peripheral Aneurysms
- Keywords
- Peripheral Vascular Disease, Vascular Disease, Arterial Embolization, Arteriovenous Embolization, Venous Embolization, Embolization Coils, Peripheral Embolization Coils, Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medtronic EndovascularIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 10 Jun 2026 (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.
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.
Detailed description
The Concerto Versa™ Health Care Professional (HCP) Clinical Assessment is a multicenter, prospective per patient HCP recollection survey. Participating HCPs will document their individual use case experience following routine utilization of Concerto Versa™ in accordance with the approved device labeling. Individual use cases will be entered within 72 hours of device usage to identify periprocedural safety incidents and evaluate device performance. At least 30 use cases will be collected and aggregated from participating HCPs. This data collection is a for a single point in time, with no patient follow-up. Individual HCP responses for each case will be aggregated by a third party vendor.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients treated with Concerto Versa™ Detachable Coil | – | Device: Concerto Versa™ Detachable CoilsThe Concerto Versa™ Detachable Coil is indicated for arterial and venous embolization in adult patients requiring embolization in the peripheral vasculature. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Concerto Versa™ Detachable Coil is indicated for arterial and venous embolization in adult patients requiring embolization in the peripheral vasculature.
Key inclusion criteria (3 listed)
- Patient treated with Concerto Versa™ Detachable Coil is age ≥ 22 years at the time of procedure.
- Use of Concerto Versa™ Detachable Coil in accordance with the device labeling.
- Reporting of case within 72 hours of index procedure.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Concerto Versa™ Detachable CoilsConcerto Versa™ detachable coil is indicated for arterial and venous embolization in the peripheral vasculature | Device | Adult patients treated with Concerto Versa™ Detachable Coil |
Primary outcome
Rate of peri-procedural adverse events
Time frame: During the Index Procedure
The rate of peri-procedural adverse events related to device and/or procedure.
Rate of Technical Success
Time frame: During the Index Procedure
Technical success is defined as successful delivery and detachment of the coil, and removal of the delivery-pusher.
1 secondary outcome
Rate of Peri-procedural success
Time frame: During the Index Procedure
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 15 Oct 2026.
- Individual participant dataSharing planned: No. No patients will be engaged, and no medical records will be accessed or used. Individual HCP responses for each case will be aggregated into a final report.
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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.
John R Laird, Jr, MD principal investigator
Medtronic Endovascular
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arteriovenous Malformation and Gastrointestinal Bleed, run by Medtronic Endovascular at 3 sites in United States.
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 3 inclusion and 0 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: enrolling by invitation, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Rate of peri-procedural adverse events (time frame: During the Index Procedure). 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 15 Oct 2026.