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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: 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.

Trial locations and contacts

5 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

About this study

Official 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

Conditions

Carotid Artery Diseases, Aortic Diseases, Peripheral Arterial Diseases

Being tested

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

Medical subject headings

Carotid Artery Diseases, Aortic Diseases, Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Intergard Standard - Collagen Coated Vascular Grafts and PatchesDevice

  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 PatchesDevice

  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 PatchesDevice

  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 GraftsDevice

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Peripheral Arterial Disease Cohort: Cohort: Percentage of participants meeting primary device patency

   Primary device patency defined as freedom from device occlusion or reintervention

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

2. Aortic Disease Cohort: Percentage of participants meeting primary device patency

   Primary device patency defined as freedom from device occlusion or reintervention

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

3. Carotid Artery Disease Cohort: Percentage of participants achieving freedom from occlusion or reintervention

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

4. 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

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

5. Aortic Disease Cohort: Incidence of Major Adverse Event (MAE)

   MAE defined as major bleeding or major reintervention

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

6. Devices with antimicrobial coating: Percentage of participants achieving freedom from infection

   Freedom from infection defined as freedom from device-related infection following the procedure

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

7. Carotid Artery Disease Cohort: Incidence of Major Adverse Event (MAE)

   MAE defined as major bleeding, or stroke

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted7 Jan 2026
2. Study start19 Dec 2025
3. Primary completionJul 2027 (estimated)
4. Study completionJul 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Carotid Artery DiseasesStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.