Intervascular Post-Market Clinical Follow-Up (PMCF) Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIntervascular
About this trial
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
Qualifiers
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.
Disqualifiers
Active infection in the region of device placement at the time of implantation of the Intergard Standard and Hemashield Vascular Graft or Patch.
Trial design
Treatments tested in this trial
- 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
Treatment groups
1,200 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov