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
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Intervascular
- Enrollment
- 1,200
- Locations
- 3
- Primary Endpoint
- Peripheral Arterial Disease Cohort: Cohort: Percentage of participants meeting primary device patency
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Carotid Artery Disease Cohort
Intervention: Intergard Standard - Collagen Coated Vascular Grafts and Patches (Device)
Carotid Artery Disease Cohort
Intervention: Hemashield - Collagen Coated Vascular Grafts and Patches (Device)
Aortic Disease Cohort
Intervention: Intergard Silver - Antimicrobial Collagen Coated Vascular Grafts and Patches (Device)
Aortic Disease Cohort
Intervention: Intergard Synergy - Antimicrobial Collagen Coated Vascular Grafts (Device)
Aortic Disease Cohort
Intervention: Intergard Standard - Collagen Coated Vascular Grafts and Patches (Device)
Aortic Disease Cohort
Intervention: Hemashield - Collagen Coated Vascular Grafts and Patches (Device)
Peripheral Arterial Disease (PAD) Cohort
Intervention: Intergard Standard - Collagen Coated Vascular Grafts and Patches (Device)
Peripheral Arterial Disease (PAD) Cohort
Intervention: Hemashield - Collagen Coated Vascular Grafts and Patches (Device)
Peripheral Arterial Disease (PAD) Cohort
Intervention: Intergard Silver - Antimicrobial Collagen Coated Vascular Grafts and Patches (Device)
Peripheral Arterial Disease (PAD) Cohort
Intervention: Intergard Synergy - Antimicrobial Collagen Coated Vascular Grafts (Device)
Outcomes
Primary Outcomes
Peripheral Arterial Disease Cohort: Cohort: Percentage of participants meeting primary device patency
Time Frame: Procedure/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 patency
Time Frame: Procedure/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 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
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)
Time Frame: 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 infection
Time Frame: Procedure/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)
Time Frame: Procedure/surgery through registry completion, anticipated average of 5 years
MAE defined as major bleeding, or stroke
Secondary Outcomes
- 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)
- Peripheral Arterial Disease Cohort: Rate of change in Rutherford Category(Procedure/surgery through registry completion, anticipated average of 5 years)
- Peripheral Arterial Disease Cohort: Rate of change in Ankle-Brachial Index(Procedure/surgery through registry completion, anticipated average of 5 years)
- Aortic Disease Cohort: Percentage of patients meeting primary-assisted device patency(Procedure/surgery through registry completion, anticipated average of 5 years)
- Aortic Disease Cohort: Percentage of patients meeting secondary device patency(Procedure/surgery through registry completion, anticipated average of 5 years)