RecruitingNCT07322913

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

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

Sponsor

Intervascular

Enrollment

1,200 participants

Start Date

Dec 19, 2025

Study Type

OBSERVATIONAL

Conditions

Aortic Diseases Carotid Artery Diseases Peripheral Arterial Diseases

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Hemashield - Collagen Coated Vascular Grafts and Patches, a medical device called Intergard Silver - Antimicrobial Collagen Coated Vascular Grafts and Patches, and others for people with aortic diseases, carotid artery diseases, and other related conditions. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIntergard Standard - Collagen Coated Vascular Grafts and Patches

Intergard Standard, Collagen coated vascular grafts and patches are made of knitted (knitted or knitted ultrathin) or woven polyester. The products are coated with a highly purified form of cross-linked bovine collagen to minimize intraoperative bleeding and eliminate the need for preclotting at the time of implant. Note that the radially supported grafts have a polypropylene supportive coil designed to resist kinking and compression of extra-anatomical vascular repair, where potential unwanted mechanical compression of the graft may occur.

DEVICEHemashield - Collagen Coated Vascular Grafts and Patches

Hemashield Vascular Grafts and Patches are made of knitted or woven polyester. The products are impregnated with a highly purified bovine collagen to reduce bleeding at the time of implant and thereby eliminates the operative preclotting step.

DEVICEIntergard Silver - Antimicrobial Collagen Coated Vascular Grafts and Patches

Intergard Silver antimicrobial collagen coated vascular grafts are made of knitted (knitted or knitted ultrathin) or woven polyester. The Hemapatch Silver Ultrathin is a surgical patch made from knitted ultrathin polyester fabric. The products are coated with a highly purified form of cross-linked bovine collagen to minimize intraoperative bleeding and eliminate the need for preclotting at the time of implant. In addition to collagen coating, the collagen matrix of Intergard Silver vascular grafts and patches is loaded with an antimicrobial agent: silver acetate. The coating of silver is designed to inhibit the microbial colonization on the device and within tissue immediately proximate to the device in the acute post-operative phase.

DEVICEIntergard Synergy - Antimicrobial Collagen Coated Vascular Grafts

Intergard Synergy antimicrobial collagen coated vascular grafts are made of knitted (knitted or knitted ultrathin) polyester. The products are coated with a highly purified form of cross-linked bovine collagen to minimize intraoperative bleeding and eliminate the need for preclotting at the time of implant. In addition to collagen coating, the collagen matrix of Intergard Synergy Antimicrobial collagen coated vascular grafts is loaded with antimicrobial agents: silver acetate and triclosan. The addition of silver acetate and triclosan on collagen coated vascular products is designed to inhibit the microbial colonization on the device and in the surrounding tissues in the acute postoperative phase.