Intervascular post-market clinical follow-up registry

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

Registry ID
ISRCTN17007574
Source registry
ISRCTN
Status
Recruiting
Phase
PHASE4
Study type
OBSERVATIONAL
Sponsor
Intervascular SAS
Enrollment
1200
Start date
2025-12-19
Completion date
2026-12-31
Last update
2026-08-17

Conditions

Summary

Peripheral arterial disease (PAD), aortic disease, carotid artery disease (CAD)

Detailed description

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 physician judgement. No intervention or follow-up assessments are stipulated. 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).

Interventions

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

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

Locations

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