Intervascular Post-Market Clinical Follow-Up (PMCF) Registry for Vascular Grafts and Patches

This study is a registry to understand the long-term safety and performance of several Intervascular products: Intergard Standard, Hemashield, Intergard Silver, and Intergard Synergy. These are collagen-coated grafts and patches used for bypass, repair, or replacement of arteries in the neck (carotid), main body artery (aorta), or legs/arms (peripheral). We want to see how well these devices work over time, including how long they stay open and if the antimicrobial coatings are helpful. You can join if you are 18 or older and have had surgery using one of these Intervascular grafts or patches. The study aims to follow 1200 participants to see how well the devices perform for about 5 years.

Study design: This is an observational study, meaning researchers will collect information without giving you a specific treatment. It plans to include 1200 participants.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed from the time of their procedure/surgery through the completion of the registry, which is anticipated to be an average of 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting

Not specifiedAges 18+Observational

Intervascular

~1,200 participants

Updated 2026-06-15 on ClinicalTrials.gov

What's tested:Intergard Standard - Collagen Coated Vascular Grafts and PatchesHemashield - Collagen Coated Vascular Grafts and PatchesIntergard Silver - Antimicrobial Collagen Coated Vascular Grafts and PatchesIntergard Synergy - Antimicrobial Collagen Coated Vascular Grafts

At a glance

Recruiting sites

4 of 4 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

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

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

+6 more outcomes measured

Conditions

Carotid Artery Diseases

Aortic Diseases

Peripheral Arterial Diseases

Where it's being run

4 sites across 3 states

Pennsylvania2

France1

Spain1

Study leadership

Director, Clinical Affairs · STUDY_DIRECTOR · Getinge

Who to contact

Senior Manager, Clinical Affairs

[email protected]

+1 603 233 7685

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

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

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