NCT07322913 · Intervascular
Intervascular Post-Market Clinical Follow-Up (PMCF) Registry
What this study is about
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.
View original scientific description
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
DEVICE
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.
DEVICE
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.
DEVICE
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.
DEVICE
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.
Primary outcome measures
Peripheral Arterial Disease Cohort: Cohort: Percentage of participants meeting primary device patency
Time frame: 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
Time frame: 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
Time frame: Procedure/surgery through registry completion, anticipated average of 5 years
Peripheral Arterial Disease Cohort: Incidence of Major Adverse Limb Events (MALE)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: Procedure/surgery through registry completion, anticipated average of 5 years
MAE defined as major bleeding, or stroke
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Hershey, Pennsylvania
- Pittsburgh, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 15, 2026 · Source of record for eligibility and locations