An observational study in Carotid Artery Diseases, Aortic Diseases and Peripheral Arterial Diseases, sponsored by Intervascular. Recruiting at 5 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Intervascular · Observational
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.
259 studies on the registry are indexed under Carotid Artery Diseases; 60 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 203 across 114 observational studies indexed under Carotid Artery Diseases.
Browse Carotid Artery Diseases studies →This is the only study on the registry with Intervascular as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Device: Intergard Standard - Collagen Coated Vascular Grafts and Patches · Device: Hemashield - 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 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 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 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.
Peripheral Arterial Disease Cohort: Cohort: Percentage of participants meeting primary device patency
Primary device patency defined as freedom from device occlusion or reintervention
Time frame: 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
Time frame: Procedure/surgery through registry completion, anticipated average of 5 years
Carotid Artery Disease Cohort: Percentage of participants achieving freedom from occlusion or reintervention
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Procedure/surgery through registry completion, anticipated average of 5 years
Carotid Artery Disease Cohort: Incidence of Major Adverse Event (MAE)
MAE defined as major bleeding, or stroke
Time frame: Procedure/surgery through registry completion, anticipated average of 5 years
All cohorts: Percentage of participants achieving technical success
Technical success defined as restoration of flow or repair of a vessel without any device deficiencies
Time frame: Procedure/surgery through registry completion, anticipated average of 5 years
All cohorts: Incidence of reported complications and events
Reported complications and events include device infection, registry or device-related serious incident or death
Time frame: Procedure/surgery through registry completion, anticipated average of 5 years
All cohorts: Incidence of infection
Time frame: 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
Time frame: 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
Time frame: Procedure/surgery through registry completion, anticipated average of 5 years
Peripheral Arterial Disease Cohort: Rate of change in Rutherford Category
Time frame: Procedure/surgery through registry completion, anticipated average of 5 years
Peripheral Arterial Disease Cohort: Rate of change in Ankle-Brachial Index
Time frame: 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
Time frame: 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
Time frame: Procedure/surgery through registry completion, anticipated average of 5 years
Plan to share: No
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