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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peripheral Arterial Disease (PAD) Cohort |
| ||
| Aortic Disease Cohort |
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| Carotid Artery Disease Cohort |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intergard Standard - Collagen Coated Vascular Grafts and Patches | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral Arterial Disease Cohort: Cohort: Percentage of participants meeting primary device patency | Primary device patency defined as freedom from device occlusion or reintervention | Procedure/surgery through registry completion, anticipated average of 5 years |
| Aortic Disease Cohort: Percentage of participants meeting primary device patency | Primary device patency defined as freedom from device occlusion or reintervention | Procedure/surgery through registry completion, anticipated average of 5 years |
| 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) | MALE defined as major amputation or major reintervention, including placement of a new bypass graft, interposition graft, thrombectomy, or thrombolysis | Procedure/surgery through registry completion, anticipated average of 5 years |
| Aortic Disease Cohort: Incidence of Major Adverse Event (MAE) | MAE defined as major bleeding or major reintervention | Procedure/surgery through registry completion, anticipated average of 5 years |
| Devices with antimicrobial coating: Percentage of participants achieving freedom from infection | Freedom from infection defined as freedom from device-related infection following the procedure | Procedure/surgery through registry completion, anticipated average of 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| All cohorts: Percentage of participants achieving technical success | Technical success defined as restoration of flow or repair of a vessel without any device deficiencies | Procedure/surgery through registry completion, anticipated average of 5 years |
| All cohorts: Incidence of reported complications and events |
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Inclusion Criteria:
Exclusion Criteria:
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An approximate 1,200 participants (400 treated for Aortic Disease, 400 treated for Peripheral Arterial Disease, and 400 treated for Carotid Artery Disease) from up to 25 sites across the United States and Europe will participate in this registry. The number of participants and sites included will ensure a representation of the overall population, specifically in vascular surgery. No mandated procedures, assessments or visits will be implemented, given the non-interventional and retrospective nature of the registry.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager, Clinical Affairs | Contact | +1 603 233 7685 | kristen.nolin@getinge.com |
| Name | Affiliation | Role |
|---|---|---|
| Director, Clinical Affairs | Getinge | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Pennsylvania State University and The Milton S. Hershey Medical Center | Recruiting | Hershey | Pennsylvania | 17033 | United States |
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| Hemashield - Collagen Coated Vascular Grafts and Patches | Device | 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 | Device | 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 | Device | 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. |
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| Carotid Artery Disease Cohort: Incidence of Major Adverse Event (MAE) | MAE defined as major bleeding, or stroke | 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 |
| Procedure/surgery through registry completion, anticipated average of 5 years |
| All cohorts: Incidence of infection | Procedure/surgery through 30 days |
| Peripheral Arterial Disease Cohort: Percentage of patients meeting primary-assisted device patency | Primary-assisted device patency is defined as freedom from device occlusion irrespective of whether an intervention was performed | Procedure/surgery through registry completion, anticipated average of 5 years |
| Peripheral Arterial Disease Cohort: Percentage of patients meeting secondary device patency | Secondary device patency is defined as freedom from "permanent" loss of device patency determined through the last follow-up time point for each patient | Procedure/surgery through registry completion, anticipated average of 5 years |
| 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 | Primary-assisted device patency is defined as freedom from device occlusion irrespective of whether an intervention was performed | Procedure/surgery through registry completion, anticipated average of 5 years |
| Aortic Disease Cohort: Percentage of patients meeting secondary device patency | Secondary device patency is defined as freedom from "permanent" loss of device patency determined through the last follow-up time point for each patient | Procedure/surgery through registry completion, anticipated average of 5 years |
| Allegheny General Hospital | Recruiting | Pittsburgh | Pennsylvania | 15212 | United States |
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| CHU Dijon Bourgogne | Recruiting | Dijon | France |
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| Hospital Universitario de Navarra | Recruiting | Pamplona | Spain |
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| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D001018 | Aortic Diseases |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D016491 | Peripheral Vascular Diseases |
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| ID | Term |
|---|---|
| D057968 | Transdermal Patch |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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