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

Condition(s) studied

Investigational drug(s) / intervention(s)

Intergard 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.

Hemashield - 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.

Intergard 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.

Intergard 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.

Study 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

Primary outcome measure(s)

• Peripheral Arterial Disease Cohort: Cohort: Percentage of participants meeting primary device patency — Procedure/surgery through registry completion, anticipated average of 5 years
  Primary device patency defined as freedom from device occlusion or reintervention
• Aortic Disease Cohort: Percentage of participants meeting primary device patency — Procedure/surgery through registry completion, anticipated average of 5 years
  Primary device patency defined as freedom from device occlusion or reintervention
• Carotid Artery Disease Cohort: Percentage of participants achieving freedom from occlusion or reintervention — Procedure/surgery through registry completion, anticipated average of 5 years
• Peripheral Arterial Disease Cohort: Incidence of Major Adverse Limb Events (MALE) — Procedure/surgery through registry completion, anticipated average of 5 years
  MALE defined as major amputation or major reintervention, including placement of a new bypass graft, interposition graft, thrombectomy, or thrombolysis
• Aortic Disease Cohort: Incidence of Major Adverse Event (MAE) — Procedure/surgery through registry completion, anticipated average of 5 years
  MAE defined as major bleeding or major reintervention
• Devices with antimicrobial coating: Percentage of participants achieving freedom from infection — Procedure/surgery through registry completion, anticipated average of 5 years
  Freedom from infection defined as freedom from device-related infection following the procedure
• Carotid Artery Disease Cohort: Incidence of Major Adverse Event (MAE) — Procedure/surgery through registry completion, anticipated average of 5 years
  MAE defined as major bleeding, or stroke

Trial sites (5)

Other trials for the same condition