Intervascular Post-Market Clinical Follow-Up (PMCF) Registry

Intervascular

Status: Enrolling

Conditions: Aortic Diseases; Peripheral Arterial Diseases; Carotid Artery Diseases

Treatments: Device: Intergard Synergy - Antimicrobial Collagen Coated Vascular Grafts; Device: Intergard Silver - Antimicrobial Collagen Coated Vascular Grafts and Patches; Device: Hemashield - Collagen Coated Vascular Grafts and Patches; Device: Intergard Standard - Collagen Coated Vascular Grafts and Patches

Study type: Observational

Funder types: Industry

Identifiers

NCT07322913

VV-TMF-00090

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,200 participants in 3 patient groups

Peripheral Arterial Disease (PAD) Cohort

Treatment:

Device: Intergard Standard - Collagen Coated Vascular Grafts and Patches

Device: Hemashield - Collagen Coated Vascular Grafts and Patches

Device: Intergard Silver - Antimicrobial Collagen Coated Vascular Grafts and Patches

Device: Intergard Synergy - Antimicrobial Collagen Coated Vascular Grafts

Aortic Disease Cohort

Treatment:

Device: Intergard Standard - Collagen Coated Vascular Grafts and Patches

Device: Hemashield - Collagen Coated Vascular Grafts and Patches

Device: Intergard Silver - Antimicrobial Collagen Coated Vascular Grafts and Patches

Device: Intergard Synergy - Antimicrobial Collagen Coated Vascular Grafts

Carotid Artery Disease Cohort

Treatment:

Device: Intergard Standard - Collagen Coated Vascular Grafts and Patches

Device: Hemashield - Collagen Coated Vascular Grafts and Patches