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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Carotid Artery Diseases; Aortic Diseases; Peripheral Arterial Diseases
• Intervention / Treatment: Device: Intergard Standard - Collagen Coated Vascular Grafts and Patches; Device: Hemashield - Collagen Coated Vascular Grafts and Patches; Device: Intergard Silver - Antimicrobial Collagen Coated Vascular Grafts and Patches; Device: Intergard Synergy - Antimicrobial Collagen Coated Vascular Grafts

• Study Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

• Study Contact: Name: Senior Manager, Clinical Affairs; Phone Number: +1 603 233 7685; Email: kristen.nolin@getinge.com

Study Locations

• France
  • Dijon, France
    • Active, not recruiting
    • Chu Dijon Bourgogne
• Spain
  • Pamplona, Spain
    • Recruiting
    • Hospital Universitario de Navarra
    • Contact: Andrea Lombarte Serrat; Phone Number: +(34) 848 422 102; Email: alombars@navarra.es
    • Principal Investigator: Esther Martinez Aguilar
• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Recruiting
      • Allegheny General Hospital
      • Contact: Sheila Bernardini; Phone Number: 412-359-3281; Email: sheila.bernardini@AHN.org
      • Principal Investigator: Satish Muluk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Peripheral Arterial Disease (PAD) Cohort	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.
Aortic Disease Cohort	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.
Carotid Artery Disease Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral Arterial Disease Cohort: Cohort: Percentage of participants meeting primary device patency	Primary device patency defined as freedom from device occlusion or reintervention	Procedure/surgery through registry completion, anticipated average of 5 years
Aortic Disease Cohort: Percentage of participants meeting primary device patency	Primary device patency defined as freedom from device occlusion or reintervention	Procedure/surgery through registry completion, anticipated average of 5 years
Carotid Artery Disease Cohort: Percentage of participants achieving freedom from occlusion or reintervention		Procedure/surgery through registry completion, anticipated average of 5 years
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	Procedure/surgery through registry completion, anticipated average of 5 years
Aortic Disease Cohort: Incidence of Major Adverse Event (MAE)	MAE defined as major bleeding or major reintervention	Procedure/surgery through registry completion, anticipated average of 5 years
Devices with antimicrobial coating: Percentage of participants achieving freedom from infection	Freedom from infection defined as freedom from device-related infection following the procedure	Procedure/surgery through registry completion, anticipated average of 5 years
Carotid Artery Disease Cohort: Incidence of Major Adverse Event (MAE)	MAE defined as major bleeding, or stroke	Procedure/surgery through registry completion, anticipated average of 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cohorts: Percentage of participants achieving technical success	Technical success defined as restoration of flow or repair of a vessel without any device deficiencies	Procedure/surgery through registry completion, anticipated average of 5 years
All cohorts: Incidence of reported complications and events	Reported complications and events include device infection, registry or device-related serious incident or death	Procedure/surgery through registry completion, anticipated average of 5 years
All cohorts: Incidence of infection		Procedure/surgery through 30 days
Peripheral Arterial Disease Cohort: Percentage of patients meeting primary-assisted device patency	Primary-assisted device patency is defined as freedom from device occlusion irrespective of whether an intervention was performed	Procedure/surgery through registry completion, anticipated average of 5 years
Peripheral Arterial Disease Cohort: Percentage of patients meeting secondary device patency	Secondary device patency is defined as freedom from "permanent" loss of device patency determined through the last follow-up time point for each patient	Procedure/surgery through registry completion, anticipated average of 5 years
Peripheral Arterial Disease Cohort: Rate of change in Rutherford Category		Procedure/surgery through registry completion, anticipated average of 5 years
Peripheral Arterial Disease Cohort: Rate of change in Ankle-Brachial Index		Procedure/surgery through registry completion, anticipated average of 5 years
Aortic Disease Cohort: Percentage of patients meeting primary-assisted device patency	Primary-assisted device patency is defined as freedom from device occlusion irrespective of whether an intervention was performed	Procedure/surgery through registry completion, anticipated average of 5 years
Aortic Disease Cohort: Percentage of patients meeting secondary device patency	Secondary device patency is defined as freedom from "permanent" loss of device patency determined through the last follow-up time point for each patient	Procedure/surgery through registry completion, anticipated average of 5 years

Collaborators and Investigators

• Sponsor: Intervascular
• Investigators: Study Director: Director, Clinical Affairs, Getinge

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Carotid Artery Diseases; Peripheral Arterial Disease; Aortic Diseases; Equipment and Supplies; Transdermal Patch
• Other Study ID Numbers: VV-TMF-00090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No