Recruiting NCT07322913
Intervascular Post-Market Clinical Follow-Up (PMCF) Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intergard Standard - Collagen Coated Vascular Grafts and Patches, Hemashield - Collagen Coated Vascular Grafts and Patches, Intergard Silver - Antimicrobial Collagen Coated Vascular Grafts and Patches, Intergard Synergy - Antimicrobial Collagen Coated Vascular Grafts.
- Who it may be relevant to
- Registry conditions: Carotid Artery Diseases, Aortic Diseases, Peripheral Arterial Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, France, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- 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 - 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 graf - 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
Primary outcome measures
- Peripheral Arterial Disease Cohort: Cohort: Percentage of participants meeting primary device patency [Time frame: Procedure/surgery through registry completion, anticipated average of 5 years]
- Aortic Disease Cohort: Percentage of participants meeting primary device patency [Time frame: Procedure/surgery through registry completion, anticipated average of 5 years]
- 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]
- Peripheral Arterial Disease Cohort: Incidence of Major Adverse Limb Events (MALE) [Time frame: Procedure/surgery through registry completion, anticipated average of 5 years]
- Aortic Disease Cohort: Incidence of Major Adverse Event (MAE) [Time frame: Procedure/surgery through registry completion, anticipated average of 5 years]
- Devices with antimicrobial coating: Percentage of participants achieving freedom from infection [Time frame: Procedure/surgery through registry completion, anticipated average of 5 years]
- Carotid Artery Disease Cohort: Incidence of Major Adverse Event (MAE) [Time frame: Procedure/surgery through registry completion, anticipated average of 5 years]
Secondary outcome measures (9)
- All cohorts: Percentage of participants achieving technical success [Time frame: Procedure/surgery through registry completion, anticipated average of 5 years]
- All cohorts: Incidence of reported complications and events [Time frame: Procedure/surgery through registry completion, anticipated average of 5 years]
- All cohorts: Incidence of infection [Time frame: Procedure/surgery through 30 days]
- Peripheral Arterial Disease Cohort: Percentage of patients meeting primary-assisted device patency [Time frame: Procedure/surgery through registry completion, anticipated average of 5 years]
- Peripheral Arterial Disease Cohort: Percentage of patients meeting secondary device patency [Time frame: Procedure/surgery through registry completion, anticipated average of 5 years]
- Peripheral Arterial Disease Cohort: Rate of change in Rutherford Category [Time frame: Procedure/surgery through registry completion, anticipated average of 5 years]
- Peripheral Arterial Disease Cohort: Rate of change in Ankle-Brachial Index [Time frame: Procedure/surgery through registry completion, anticipated average of 5 years]
- Aortic Disease Cohort: Percentage of patients meeting primary-assisted device patency [Time frame: Procedure/surgery through registry completion, anticipated average of 5 years]
- Aortic Disease Cohort: Percentage of patients meeting secondary device patency [Time frame: Procedure/surgery through registry completion, anticipated average of 5 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- The Pennsylvania State University and The Milton S. Hershey Medical Center — Hershey
- Allegheny General Hospital — Pittsburgh
France · 1 center
- CHU Dijon Bourgogne — Dijon
Spain · 1 center
- Hospital Universitario de Navarra — Pamplona
Identifiers
NCT: NCT07322913 · VV-TMF-00090