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Creating a registry of data of patients who have undergone endovascular reconstruction for aortic occlusive disease to assess treatment outcomes

Covered Stents vs Bare Metal Stent Endovascular Reconstruction for Aortic Occlusive Disease (COBRA registry)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN19619299
Enrollment
Unknown
Registered
2020-05-05
Start date
2016-05-01
Completion date
Unknown
Last updated
2020-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortoiliac steno-occlusive arterial disease with ischaemic pain at rest or when walking (claudication) or tissue loss (gangrene) Circulatory System Claudication, gangrene

Interventions

This is an observational trial using retrospective data. Patients will receive standard clinical care as per best available evidence, local/regional/national care pathways, and physicians' preference

Sponsors

Guy's and St Thomas' NHS Foundation Trust
Lead Sponsor
St. Franziskus Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Infrarenal chronic aorto-iliac occlusive/stenotic symptomatic disease for >14 Days 2. Treatment by an aortic stent graft or bare metal stent with or without iliac stenting

Exclusion criteria

Exclusion criteria: 1. Acute aortic occlusive disease 2. Aneurysm related interventions 3. Previous aorto-iliac stenting or In-Stent-Restenosis 4. Aortic coarctation 5. Isolated Kissing-Stent-Reconstruction without aortic stents 6. Aortic injury/trauma related interventions 7. Suprarenal/visceral segment reconstructions

Design outcomes

Primary

MeasureTime frame
Re-intervention-free-survival, defined as the composite endpoint of target lesion revascularization (TLR) and/or death, whichever occurred first, obtained from clinician notes collected at day of discharge from hospital, 30 days after the procedure, and latest available follow-up.

Secondary

MeasureTime frame
The following outcome measures will be obtained from clinician notes, collected at day of discharge from hospital, 30 days after the procedure, and latest available follow-up 1. Acute technical success 2. 30-days morbidity 3. 30-days mortality 4. Overall mortality 5. Conversion-to-surgery free time 6. Re-intervention free time

Countries

Belgium, France, Germany, Greece, Italy, Netherlands, Spain, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026