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

NCT07322913 | Recruiting FDA Device

• 1 other identifier: VV-TMF-00090
• Study Type: observational
• Target: 1,200
• Locations: 3 countries
• Sites: 3

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

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (9)

• All cohorts: Percentage of participants achieving technical success

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

• All cohorts: Incidence of reported complications and events

  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

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

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

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

Study Arms (3)

Peripheral Arterial Disease (PAD) Cohort

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

Aortic Disease Cohort

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

Carotid Artery Disease Cohort

Device: Intergard Standard - Collagen Coated Vascular Grafts and Patches; Device: Hemashield - Collagen Coated Vascular Grafts and Patches

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.

Aortic Disease Cohort; Carotid Artery Disease Cohort; Peripheral Arterial Disease (PAD) Cohort

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.

Aortic Disease Cohort; Carotid Artery Disease Cohort; Peripheral Arterial Disease (PAD) Cohort

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.

Aortic Disease Cohort; Peripheral Arterial Disease (PAD) Cohort

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.

Aortic Disease Cohort; Peripheral Arterial Disease (PAD) Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Active infection in the region of device placement at the time of implantation of the Intergard Standard and Hemashield Vascular Graft or Patch.

Sponsors & Collaborators

• Intervascular: lead

Study Sites (3)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

CHU Dijon Bourgogne

Dijon, France

ACTIVE NOT RECRUITING

Hospital Universitario de Navarra

Pamplona, Spain

RECRUITING

MeSH Terms

Conditions

Carotid Artery Diseases; Aortic Diseases; Peripheral Arterial Disease

Interventions

Transdermal Patch

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Director, Clinical Affairs

  Getinge

  STUDY DIRECTOR

Central Study Contacts

Senior Manager, Clinical Affairs

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: January 7, 2026
• Study Start: December 19, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); US (1); FR (1)