Recruiting

Vascular Grafts & PatchesIntervascular Post-Market Clinical Follow-Up (PMCF) Registry

Sponsor:

Intervascular

Code:

NCT07322913

Conditions

Carotid Artery Diseases

Aortic Diseases

Peripheral Arterial Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intergard Standard - Collagen Coated Vascular Grafts and Patches

Hemashield - Collagen Coated Vascular Grafts and Patches

Intergard Silver - Antimicrobial Collagen Coated Vascular Grafts and Patches

Intergard Synergy - Antimicrobial Collagen Coated Vascular Grafts

Study Details

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.

Conditions

Carotid Artery Diseases

Aortic Diseases

Peripheral Arterial Diseases

Study ID

NCT07322913

Start date

Dec 19, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1200 participants

Anticipated

Interventions and Outcome Measures

Arms

Peripheral Arterial Disease (PAD) Cohort

Aortic Disease Cohort

Carotid Artery Disease Cohort

Interventions

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.

Primary outcome measure

Peripheral Arterial Disease Cohort: Cohort: Percentage of participants meeting primary device patency [ Time Frame: Procedure/surgery through registry completion, anticipated average of 5 years ]
Aortic Disease Cohort: Percentage of participants meeting primary device patency [ 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) [ Time Frame: Procedure/surgery through registry completion, anticipated average of 5 years ]
Aortic Disease Cohort: Incidence of Major Adverse Event (MAE) [ Time Frame: Procedure/surgery through registry completion, anticipated average of 5 years ]
Devices with antimicrobial coating: Percentage of participants achieving freedom from infection [ Time Frame: Procedure/surgery through registry completion, anticipated average of 5 years ]
Carotid Artery Disease Cohort: Incidence of Major Adverse Event (MAE) [ Time Frame: Procedure/surgery through registry completion, anticipated average of 5 years ]

Central Contacts and Locations

Central contacts

Senior Manager, Clinical Affairs

+1 603 233 7685 kristen.nolin@getinge.com

Locations

The Pennsylvania State University and The Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Margaret McConnell

717-531-5966 mmcconnell2@pennstatehealth.psu.edu

Principal Investigator:

Faisal Aziz

Allegheny General Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Sheila Bernardini

412-359-3281 sheila.bernardini@AHN.org

Principal Investigator:

Satish Muluk

More Information

Sponsor

Intervascular

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Intervascular on 2026-06-15.