Long-term follow-up of Intergard vascular grafts and patches
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
Intervascular · NCT07322913
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 |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Intervascular (industry) |
| Locations | 3 sites (Pittsburgh, Pennsylvania and 2 other locations) |
| Trial ID | NCT07322913 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Pittsburgh, Pennsylvania and 2 other locations
- Allegheny General Hospital — Pittsburgh, Pennsylvania, United States (RECRUITING)
- CHU Dijon Bourgogne — Dijon, France (ACTIVE_NOT_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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Carotid Artery Diseases, Aortic Diseases, Peripheral Arterial Diseases