NCT07322913 Intervascular Post-Market Clinical Follow-Up (PMCF) Registry
| NCT ID | NCT07322913 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Intervascular |
| Condition | Carotid Artery Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2025-12-19 |
| Primary Completion | 2027-07 |
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 1,200 participants in total. It began in 2025-12-19 with a primary completion date of 2027-07.
⚠ 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 this registry is to evaluate the long-term safety and performance of Intervascular Vascular Grafts and Patches (Intergard Standard, Hemashield, Intergard Silver, Intergard Synergy) for bypass, repair or replacement of aortic, peripheral, or carotid arteries. This registry is intended to further define the expected product lifetime of the devices and to collect data related to usefulness of the antimicrobial coatings.
Eligibility Criteria
Inclusion Criteria: * Willing, and able to provide legally-effective written informed consent (as required by Institutional Review Board or Ethics Committee) * Male and female patients that have undergone bypass, replacement or repair of the peripheral arteries, aorta, or carotid artery using the Intervascular Vascular Grafts and Patches (Intergard Standard, Hemashield, Intergard Silver, Intergard Synergy) * Were at least 18 years of age at the time of the procedure * Available records for data collection with a minimum of 3 years (36 months) of data/follow-up. Exclusion Criteria: * Active infection in the region of device placement at the time of implantation of the Intergard Standard and Hemashield Vascular Graft or Patch.
Contact & Investigator
Director, Clinical Affairs
STUDY DIRECTOR
Getinge
Frequently Asked Questions
Who can join the NCT07322913 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Carotid Artery Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07322913 currently recruiting?
Yes, NCT07322913 is actively recruiting participants. Contact the research team at kristen.nolin@getinge.com for enrollment information.
Where is the NCT07322913 trial being conducted?
This trial is being conducted at Hershey, United States, Pittsburgh, United States, Leuven, Belgium, Dijon, France and 1 additional location.
Who is sponsoring the NCT07322913 clinical trial?
NCT07322913 is sponsored by Intervascular. The principal investigator is Director, Clinical Affairs at Getinge. The trial plans to enroll 1,200 participants.