Health TrialsbyHealthPanel

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

ConditionsCarotid Artery DiseasesAortic DiseasesPeripheral Arterial Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIntervascular

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial 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 design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

  • 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.

Treatment groups

1,200 Participants
are divided into 3 treatment groups
Group A: Peripheral Arterial Disease (PAD) Cohort4 interventions
Group B: Aortic Disease Cohort4 interventions
Group C: Carotid Artery Disease Cohort2 interventions

Trial outcomes

Primary outcomes

1

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

Primary device patency defined as freedom from device occlusion or reintervention

Time frame
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

Time frame
Procedure/surgery through registry completion, anticipated average of 5 years
3

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

Time frame
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

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

Secondary outcomes

1

All cohorts: Percentage of participants achieving technical success

Technical success defined as restoration of flow or repair of a vessel without any device deficiencies

Time frame
Procedure/surgery through registry completion, anticipated average of 5 years
2

All cohorts: Incidence of reported complications and events

Reported complications and events include device infection, registry or device-related serious incident or death

Time frame
Procedure/surgery through registry completion, anticipated average of 5 years
3

All cohorts: Incidence of infection

Time frame
Procedure/surgery through 30 days
4

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Intervascular

Lead sponsor

Source ClinicalTrials.gov
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