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Long-term follow-up of vascular grafts and patches for artery surgery

Follows adults receiving vascular grafts or patches for aortic, leg or neck artery disease.

Key facts

Who runs it
Intervascular
Where
Hershey and Pittsburgh, United StatesSee the 2 sitesAlso in 3 other countries, 3 sites
Trial code
Registry title
Intervascular Post-Market Clinical Follow-Up (PMCF) Registry
Status
Recruiting
People taking part
1,200 people, planned
Started
19 Dec 2025
Expected to end
Jul 2027
Type of study
Observational, 3 groups
Treatments tested
  • Intergard Standard - Collagen Coated Vascular Grafts and Patches
  • Hemashield - Collagen Coated Vascular Grafts and Patches
  • Intergard Silver - Antimicrobial Collagen Coated Vascular Grafts and Patches
  • Intergard Synergy - Antimicrobial Collagen Coated Vascular Grafts
Record updated
11 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who already had surgery on the aorta, leg or neck arteries using Intervascular grafts or patches. It collects their records to study long-term safety and performance.

Age
At least 18 years old at the time of the procedure.
Sex
Men and women.
Disease stage
Disease of the aorta, the peripheral arteries or the carotid artery, treated by bypass, replacement or repair.
Earlier treatment
People must have had bypass, replacement or repair using Intergard Standard, Hemashield, Intergard Silver or Intergard Synergy grafts or patches. Records must cover at least 3 years (36 months) of follow-up.

Main reasons for not taking part

  • Active infection where the device was placed at the time the Intergard Standard or Hemashield graft or patch was put in.

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Active infection in the region of device placement at the time of implantation of the Intergard Standard and Hemashield Vascular Graft or Patch

Where in United States

Also in 3 other countries, 3 sites

  • The Pennsylvania State University and The Milton S. Hershey Medical CenterHershey, United StatesContact: Margaret McConnellTaking people
  • Allegheny General HospitalPittsburgh, United StatesContact: Sheila BernardiniTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Peripheral Arterial Disease (PAD) Cohort

    Treatment: Intergard Standard - Collagen Coated Vascular Grafts and Patches, Hemashield - Collagen Coated Vascular Grafts and Patches, Intergard Silver - Antimicrobial Collagen Coated Vascular Grafts and Patches, and Intergard Synergy - Antimicrobial Collagen Coated Vascular Grafts

  • Aortic Disease Cohort

    Treatment: Intergard Standard - Collagen Coated Vascular Grafts and Patches, Hemashield - Collagen Coated Vascular Grafts and Patches, Intergard Silver - Antimicrobial Collagen Coated Vascular Grafts and Patches, and Intergard Synergy - Antimicrobial Collagen Coated Vascular Grafts

  • Carotid Artery Disease Cohort

    Treatment: Intergard Standard - Collagen Coated Vascular Grafts and Patches and Hemashield - Collagen Coated Vascular Grafts and Patches

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Long-term follow-up of vascular grafts and patches for artery surgeryGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
11 September 2026