Long-term follow-up of Intergard vascular grafts and patches
Official title: Post-Market Clinical Follow-up Registry to Evaluate the Safety and Performance of the Intervascular Vascular Grafts and Patches in Patients Undergoing Bypass, Replacement, or Repair of Aortic, Peripheral, or Carotid Arteries
Run by Intervascular · NCT07322913 · Data updated 2026-11-12
This registry will see how Intergard grafts and patches perform and stay safe over time in adults who had bypass, repair, or replacement of the aorta, carotid, or peripheral arteries.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1200 (estimated) |
| Sponsor | Intervascular Industry-sponsored |
| Locations | 5 sites (Hershey, Pennsylvania and 4 other locations) |
| Status | Recruiting |
| Started | December 19, 2025 |
| Main results expected | July 2027 |
| Study ends | July 2027 |
| Registry record updated | September 11, 2026 |
| Trial ID | NCT07322913 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) who previously underwent bypass, replacement, or repair of the aorta, carotid, or peripheral arteries using an Intergard device and who can provide at least three years of follow-up records and informed consent are ideal candidates.
✕Probably not a fit
Patients who did not receive an Intergard device, those lacking the required medical records or consent, and patients who had an active infection at the device site at the time of implantation (for some devices) are unlikely to benefit from joining this registry.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational registry collects long-term safety and performance data on four Intervascular devices (Intergard Standard, Hemashield, Intergard Silver, Intergard Synergy) used for aortic, peripheral, or carotid bypass, repair, or replacement. Participating adults who previously received one of these grafts or patches will have existing clinical records reviewed, with a minimum of three years of follow-up data required. The registry specifically records device longevity and gathers information on the usefulness of antimicrobial coatings. Data are collected at participating centers in the US, France, and Spain without assigning new treatments.
Why it matters
Potential benefit: If successful, the registry could clarify expected device lifetime and whether antimicrobial coatings reduce complications, helping doctors choose the best graft for future patients.
How similar studies have gone: Intervascular grafts and patches are widely used and prior observational work supports their general safety, but long-term, comparative data on device lifetime and the added value of antimicrobial coatings remain limited.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
The Pennsylvania State University and The Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States Recruiting -
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States Recruiting -
UZ Leuven
Leuven, Belgium Recruiting -
CHU Dijon Bourgogne
Dijon, France Recruiting -
Hospital Universitario de Navarra
Pamplona, Spain Recruiting
Study contacts
- Study coordinator: Senior Manager, Clinical Affairs
- Email: kristen.nolin@getinge.com
- Phone: +1 603 233 7685
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Prospective cardiac surgery cohort to improve perioperative care
A multi-center study will test a large, forward-looking database of adults undergoing heart surgery to better understand what affects short- and long-term outcomes.
-
Carotid ultrasound to guide prevention of heart disease in inflammatory rheumatic diseases
In people with inflammatory rheumatic diseases like RA, PsA, AxSpA, or SLE who are at modest cardiovascular risk, a carotid ultrasound test is used to see if they should start stronger lipid-lowering therapy to prevent heart problems.
-
Aortic Diseases and Quality of Life: How Work Ability is Affected
This observational study tests how living with aortic diseases affects quality of life, fatigue, mental well-being, and the ability to work in adults aged 18 to 70.
-
Mouth bacteria and carotid artery plaque vulnerability
This project will see if mouth bacteria are linked to vulnerable carotid plaques in adults having carotid endarterectomy at Semmelweis University.
-
Longitudinal Assessment of Cardiac MRI Microstructure in Patients and Healthy People
This study tests advanced, non-contrast and extended clinical cardiac MRI techniques to see how heart tissue features differ between people with heart disease and healthy individuals.
-
Rapidlink device for repairing aortic arch branch vessels during open thoracic aorta surgery
This study will test whether the Rapidlink device can help surgeons repair or replace the arteries branching from the aortic arch during open surgery for thoracic aortic disease.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.