Peripheral Arterial DiseaseNCT07161583
Advanta VXT and Flixene PMCF Registry
An observational study of Peripheral Arterial Disease, run by Atrium Medical Corporation at 2 sites in 2 countries.
Trial summary
The purpose of the registry is to evaluate the long-term safety and performance of Advanta VXT and Flixene vascular grafts for repair or replacement of peripheral arteries. This registry is also intended to provide further data on the clinical usefulness of the Advanta VXT and Flixene vascular grafts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Advanta VXT Vascular Graft and Flixene Vascular Graft
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 25 Sep 2025to Dec 2027
- 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: An approximate 1,000 patients from 25 sites across the US and Europe will participate in this registry. The number of patients and sites included will ensure a representation of the overall population, specifically in vascular surgery. No mandated procedures, assessments or visits will be implemented, given the non-interventional nature of the registry.
Who may be able to join
- Willing, and able to provide legally-effective written informed consent (as required by IRB/EC)
- Male and female patients that have undergone replacement or repair of the peripheral arteries using the Advanta VXT or Flixene vascular graft.
- Were at least 18 years of age at the time of the procedure
- Available records for data collection, with a minimum of 36 months of data/follow-up.
Who cannot join
- Active infection in the region of graft placement at the time of implantation of the Advanta VXT or Flixene vascular graft
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Kaitlin Gossart, 617-726-9609, kgossart@mgh.harvard.edu
Anahita Dua
France1 site, 1 recruiting
- Recruiting
CHU de Brest
Brest, Brittany Region
Gwenaelle Desanglois, 0298347151, gwenaelle.desanglois@chu-brest.fr
Bahaa Nasr
About this study
Official title: Post-Market Clinical Follow-up Registry to Evaluate the Safety and Performance of the Atrium Advanta VXT and Flixene Vascular Grafts in Patients Undergoing Surgical Repair or Replacement of Peripheral Arteries
The purpose of the registry is to evaluate the long-term safety and performance of Advanta VXT and Flixene vascular grafts for repair or replacement of peripheral arteries. This registry is also intended to provide further data on the clinical usefulness of the Advanta VXT and Flixene vascular grafts.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Advanta VXT Vascular Graft, Flixene Vascular Graft
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanta VXT Vascular GraftDevice
The Advanta VXT graft is a two (2)-layer graft employing a single layer ePTFE graft, which is then wrapped with an additional layer of ePTFE for increased support. Some Advanta VXT configurations include Helix, which is a monofilament bead wrapped circumferentially around a portion or the entire length of the graft (such a graft is also called a Ringed Graft). The helix rings are bonded to the exterior surface of the graft. Advanta VXT Tapers are formed by changing the graft diameter, expanding from a small Inner Diameter (ID) to a larger ID (with the result that one end is larger).
Flixene Vascular GraftDevice
The Flixene vascular graft is a three (3)-layered graft comprised of ePTFE. The Flixene graft was designed with an additional layer of ePTFE. As a result of its design, ring support is not necessary
| Study group | Role | What they receive |
|---|---|---|
| Peripheral Arterial Disease (PAD) Cohort | Not described Receives: Device: Advanta VXT Vascular Graft; Device: Flixene Vascular Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants meeting Primary Efficacy Endpoint
Primary patency defined as freedom from graft occlusion or reintervention
Measured: Procedure/surgery through registry completion (a minimum of 3 years)
Percentage of Participants meeting Primary Safety Endpoint
Major Adverse Limb Events (MALE), defined as major amputation or major reintervention, including placement of a new bypass graft, interposition graft, thrombectomy, or thrombolysis
Measured: Procedure/surgery through registry completion (a minimum of 3 years)
Secondary outcomes (5)
Incidence of Reported Complications/Events
Measured: Procedure/surgery through registry completion (a minimum of 3 years)
Percentage of Participants meeting Primary-Assisted Graft Patency
Defined as freedom from graft occlusion irrespective of whether an intervention was performed; in other words, primary-assisted patency is not lost when a reintervention is performed to preserve graft patency before occlusion occurs
Measured: Procedure/surgery through registry completion (a minimum of 3 years)
Percentage of Participants meeting Secondary Graft Patency
Defined as freedom from "permanent" loss of graft patency
Measured: Procedure/surgery through registry completion (a minimum of 3 years)
Rate of change in Rutherford Category
Measured: Baseline, procedure/surgery, through registry completion (a minimum of 3 years)
Rate of change in Ankle-Brachial Index (ABI)
Measured: Baseline, procedure/surgery, through registry completion (a minimum of 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start25 Sep 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atrium Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Director, Clinical Affairs, Study director, Getinge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161583
- Sponsor's protocol ID
- DD021215-001
- Status last verified
- Sep 2026
- First submitted
- 12 Aug 2025
- Last updated
- 11 Sep 2026
- 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Follow-up Registry to Evaluate the Safety and Performance of the Atrium Advanta VXT and Flixene Vascular Grafts in Patients Undergoing Surgical Repair or Replacement of Peripheral Arteries
- ClinicalTrials.gov ID
- NCT07161583
- Acronym / sponsor ID
- DD021215-001
- Conditions
- Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Atrium Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Sep 2025 (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 registry is to evaluate the long-term safety and performance of Advanta VXT and Flixene vascular grafts for repair or replacement of peripheral arteries. This registry is also intended to provide further data on the clinical usefulness of the Advanta VXT and Flixene vascular grafts.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peripheral Arterial Disease (PAD) Cohort | – | Device: Advanta VXT Vascular Graft, Device: Flixene Vascular Graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- An approximate 1,000 patients from 25 sites across the US and Europe will participate in this registry. The number of patients and sites included will ensure a representation of the overall population, specifically in vascular surgery. No mandated procedures, assessments or visits will be implemented, given the non-interventional nature of the registry.
Key inclusion criteria (4 listed)
- Willing, and able to provide legally-effective written informed consent (as required by IRB/EC)
- Male and female patients that have undergone replacement or repair of the peripheral arteries using the Advanta VXT or Flixene vascular graft.
- Were at least 18 years of age at the time of the procedure
- Available records for data collection, with a minimum of 36 months of data/follow-up.
Key exclusion criteria (1 listed)
- Active infection in the region of graft placement at the time of implantation of the Advanta VXT or Flixene vascular graft
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 |
|---|---|---|
| Advanta VXT Vascular GraftThe Advanta VXT graft is a two (2)-layer graft employing a single layer ePTFE graft, which is then wrapped with an additional layer of ePTFE for increased support. Some Advanta VXT configurations include Helix, which is a monofilament bead wrapped circumferentially around a portion or the entire length of the graft (such a graft is also called a Ringed Graft). The helix rings are bonded to the exterior surface of the graft. Advanta VXT Tapers are formed by changing the graft diameter, expanding from a small Inner Diameter (ID) to a larger ID (with the result that one end is larger). | Device | Peripheral Arterial Disease (PAD) Cohort |
| Flixene Vascular GraftThe Flixene vascular graft is a three (3)-layered graft comprised of ePTFE. The Flixene graft was designed with an additional layer of ePTFE. As a result of its design, ring support is not necessary | Device | Peripheral Arterial Disease (PAD) Cohort |
Primary outcome
Percentage of Participants meeting Primary Efficacy Endpoint
Time frame: Procedure/surgery through registry completion (a minimum of 3 years)
Primary patency defined as freedom from graft occlusion or reintervention
Percentage of Participants meeting Primary Safety Endpoint
Time frame: Procedure/surgery through registry completion (a minimum of 3 years)
Major Adverse Limb Events (MALE), defined as major amputation or major reintervention, including placement of a new bypass graft, interposition graft, thrombectomy, or thrombolysis
5 secondary outcomes
Incidence of Reported Complications/Events
Time frame: Procedure/surgery through registry completion (a minimum of 3 years)
Percentage of Participants meeting Primary-Assisted Graft Patency
Time frame: Procedure/surgery through registry completion (a minimum of 3 years)
Percentage of Participants meeting Secondary Graft Patency
Time frame: Procedure/surgery through registry completion (a minimum of 3 years)
Rate of change in Rutherford Category
Time frame: Baseline, procedure/surgery, through registry completion (a minimum of 3 years)
Rate of change in Ankle-Brachial Index (ABI)
Time frame: Baseline, procedure/surgery, through registry completion (a minimum of 3 years)
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 11 Sep 2026.
- 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.
Director, Clinical Affairs study director
Getinge
2 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 Arterial Disease, run by Atrium Medical Corporation at 2 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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, France. 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?
Contact Senior Manager, Clinical Affairs (+1 603 233 7685, kristen.nolin@getinge.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants meeting Primary Efficacy Endpoint (time frame: Procedure/surgery through registry completion (a minimum of 3 years)). 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 11 Sep 2026.