Aortic Diseases, Carotid Artery Diseases, Peripheral Arterial Diseases
Conditions
Brief 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.
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.
Sponsors
Intervascular
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All cohorts: Percentage of participants achieving technical success | Procedure/surgery through registry completion, anticipated average of 5 years | Technical success defined as restoration of flow or repair of a vessel without any device deficiencies |
| All cohorts: Incidence of reported complications and events | Procedure/surgery through registry completion, anticipated average of 5 years | Reported complications and events include device infection, registry or device-related serious incident or death |
| All cohorts: Incidence of infection | Procedure/surgery through 30 days | — |
| Peripheral Arterial Disease Cohort: Percentage of patients meeting primary-assisted device patency | Procedure/surgery through registry completion, anticipated average of 5 years | Primary-assisted device patency is defined as freedom from device occlusion irrespective of whether an intervention was performed |
| Peripheral Arterial Disease Cohort: Percentage of patients meeting secondary device patency | Procedure/surgery through registry completion, anticipated average of 5 years | Secondary device patency is defined as freedom from "permanent" loss of device patency determined through the last follow-up time point for each patient |
| Peripheral Arterial Disease Cohort: Rate of change in Rutherford Category | Procedure/surgery through registry completion, anticipated average of 5 years | — |
| Peripheral Arterial Disease Cohort: Rate of change in Ankle-Brachial Index | Procedure/surgery through registry completion, anticipated average of 5 years | — |
| Aortic Disease Cohort: Percentage of patients meeting primary-assisted device patency | Procedure/surgery through registry completion, anticipated average of 5 years | Primary-assisted device patency is defined as freedom from device occlusion irrespective of whether an intervention was performed |
| Aortic Disease Cohort: Percentage of patients meeting secondary device patency | Procedure/surgery through registry completion, anticipated average of 5 years | Secondary device patency is defined as freedom from "permanent" loss of device patency determined through the last follow-up time point for each patient |
Countries
Belgium, France, Spain, United States
Contacts
CONTACTSenior Manager, Clinical Affairs
STUDY_DIRECTORDirector, Clinical Affairs
Getinge
Outcome results
None listed