RecruitingNot Applicable

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

United States, France, Spain1,200 participantsStarted 2025-12-19

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Aortic Disease Cohort: Percentage of participants meeting primary device patency

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

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

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

Peripheral Arterial Disease Cohort: Incidence of Major Adverse Limb Events (MALE)

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

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

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

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

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

Trial details

NCT IDNCT07322913

SponsorIntervascular

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-12

Contact for this trial

Senior Manager, Clinical Affairs

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

View on ClinicalTrials.gov More Carotid Artery Diseases trials