Peripheral arterial disease (PAD), aortic disease, carotid artery disease (CAD) Circulatory System
Conditions
Interventions
No registry-specific visits, interventions or assessments will be required by the protocol. Assessments conducted during participant visits will be according to local standard clinical practice and ph
Sponsors
Intervascular SAS
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide legally effective written informed consent (as required by IRB/EC) 2. Male and female participants 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) 3. Were at least 18 years of age at the time of the procedure 4. Available records for data collection with a minimum of 3 years (36 months) of data/follow-up
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. PAD Cohort: Primary device patency, defined as freedom from device occlusion or reintervention [time frame: through long-term follow-up] 2. Aortic Disease Cohort: Primary device patency, defined as freedom from device occlusion or reintervention [time frame: through long-term follow-up] 3. Carotid Artery Disease Cohort: Freedom from occlusion or reintervention [time frame: through long-term follow-up] 4. PAD Cohort: Major Adverse Limb Events (MALE), defined as major amputation or major reintervention, including placement of a new bypass graft, interposition graft, thrombectomy, or thrombolysis [time frame: through long-term follow-up] 5. Aortic Disease Cohort: Major Adverse Event (MAE), defined as major bleeding or major reintervention [time frame: through long-term follow-up] 6. Carotid Artery Disease Cohort: Major Adverse Event (MAE), defined as major bleeding, or stroke [time frame: through long-term follow-up] 7. Devices with antimicrobial coating: freedom from infection [time frame: through long-term follow-up] Duration of the long-term follow-up is a minimum of 3 years (36 months) and a maximum of 15 years (180 months). No specific timepoints are specified, due to the nature of this post-market retrospective, data collection registry (i.e. collecting historical standard of care data as it was noted in the medical charts). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. PAD Cohort: Technical success; reported complications and events, primary-assisted device patency, secondary device patency, and any changes in Rutherford Category and ankle brachial index (ABI). Rutherford category and ABI measurements at follow-up will be compared with baseline, where available. Primary assisted device patency is defined as freedom from device occlusion irrespective of whether an intervention was performed; in other words, primary-assisted patency is not lost when a reintervention is performed to preserve device patency before occlusion occurs. Secondary device patency is defined as freedom from “permanent” loss of device patency determined through the last follow-up time point for each patient [time frame: through long-term follow-up] 2. Aortic Disease Cohort: Technical success; reported complications and events, primary- assisted device patency and secondary device patency [time frame: through long-term follow-up] 3. Carotid Artery Disease Cohort: Technical success; reported complications and events [time frame: through long-term follow-up] 4. For all cohorts: 30-day incidence of infection; complications and events include device infection, registry or device-related serious incident, or death [time frame: 30 days] Duration of the long-term follow-up is a minimum of 3 years (36 months) and a maximum of 15 years (180 months). No specific timepoints are specified, due to the nature of this post-market retrospective, data collection registry (i.e. collecting historical standard of care data as it was noted in the medical charts). | — |
Countries
Belgium, France, Spain, United States of America
Contacts
Public ContactKristen Nolin
Outcome results
None listed