Intervascular Post-Market Clinical Follow-Up (PMCF) Registry

Part of paid clinical trials in Hershey, Pennsylvania.

Sponsor
Intervascular
Study ID
NCT07322913
Status
Recruiting
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Conditions

  • Aortic Diseases
  • Carotid Artery Diseases
  • Peripheral Arterial Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Dec 19, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
1,200 participants (estimated)

Arms

  • Arm: Peripheral Arterial Disease (PAD) Cohort
  • Arm: Aortic Disease Cohort
  • Arm: Carotid Artery Disease Cohort

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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The Pennsylvania State University and The Milton S. Hershey Medical CenterHersheyPennsylvania17033
Margaret McConnell
[email protected]
717-531-5966
Faisal Aziz (PRINCIPAL_INVESTIGATOR)
Allegheny General HospitalPittsburghPennsylvania15212
Sheila Bernardini
[email protected]
412-359-3281
Satish Muluk (PRINCIPAL_INVESTIGATOR)

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The Pennsylvania State University and The Milton S. Hershey Medical Center· Hershey, PAAllegheny General Hospital· Pittsburgh, PA

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