| NCT ID | NCT07161583 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Atrium Medical Corporation |
| Condition | Peripheral Arterial Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-09-25 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2025-09-25 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: \- Active infection in the region of graft placement at the time of implantation of the Advanta VXT or Flixene vascular graft
Contact & Investigator
Director, Clinical Affairs
STUDY DIRECTOR
Getinge
Frequently Asked Questions
Who can join the NCT07161583 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07161583 currently recruiting?
Yes, NCT07161583 is actively recruiting participants. Contact the research team at kristen.nolin@getinge.com for enrollment information.
Where is the NCT07161583 trial being conducted?
This trial is being conducted at Boston, United States, Brest, France.
Who is sponsoring the NCT07161583 clinical trial?
NCT07161583 is sponsored by Atrium Medical Corporation. The principal investigator is Director, Clinical Affairs at Getinge. The trial plans to enroll 1,000 participants.