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NCT Number: NCT07322913

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

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.

Recruiting

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Key information

Conditions

Carotid Artery Diseases Aortic Diseases Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Peripheral Arterial Disease Peripheral Arterial Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Dijon Bourgogne, Dijon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Secondary outcomes

  1. All cohorts: Percentage of participants achieving technical success

    Time frame: Procedure/surgery through registry completion, anticipated average of 5 years

    Technical success defined as restoration of flow or repair of a vessel without any device deficiencies

  2. All cohorts: Incidence of reported complications and events

    Time frame: 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

  3. All cohorts: Incidence of infection

    Time frame: Procedure/surgery through 30 days

  4. Peripheral Arterial Disease Cohort: Percentage of patients meeting primary-assisted device patency

    Time frame: Procedure/surgery through registry completion, anticipated average of 5 years

    Primary-assisted device patency is defined as freedom from device occlusion irrespective of whether an intervention was performed

  5. Peripheral Arterial Disease Cohort: Percentage of patients meeting secondary device patency

    Time frame: Procedure/surgery through registry completion, anticipated average of 5 years

    Secondary device patency is defined as freedom from "permanent" loss of device patency determined through the last follow-up time point for each patient

  6. Peripheral Arterial Disease Cohort: Rate of change in Rutherford Category

    Time frame: Procedure/surgery through registry completion, anticipated average of 5 years

  7. Peripheral Arterial Disease Cohort: Rate of change in Ankle-Brachial Index

    Time frame: Procedure/surgery through registry completion, anticipated average of 5 years

  8. Aortic Disease Cohort: Percentage of patients meeting primary-assisted device patency

    Time frame: Procedure/surgery through registry completion, anticipated average of 5 years

    Primary-assisted device patency is defined as freedom from device occlusion irrespective of whether an intervention was performed

  9. Aortic Disease Cohort: Percentage of patients meeting secondary device patency

    Time frame: Procedure/surgery through registry completion, anticipated average of 5 years

    Secondary device patency is defined as freedom from "permanent" loss of device patency determined through the last follow-up time point for each patient

Study contacts

Contact information is provided by the study sponsor or research team.

Senior Manager, Clinical Affairs

CONTACT

[email protected]

+1 603 233 7685

Sponsors and collaborators

Lead sponsor

Intervascular

Industry

Registry information

Official study title

Post-Market Clinical Follow-up Registry to Evaluate the Safety and Performance of the Intervascular Vascular Grafts and Patches in Patients Undergoing Bypass, Replacement, or Repair of Aortic, Peripheral, or Carotid Arteries

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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