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Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) for Extensive Aortoiliac Occlusive Disease

NCT03767686 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 28

Last updated 2020-04-01

No results posted yet for this study

Summary

Endovascular treatment is rapidly taking over surgery for aorto-iliac occlusive disease (AOID), also in extensive pathology. This is related to its minimally invasiveness, decreasing the procedural morbidity rate. When the aortic bifurcation was involved in the lesion, the patency rates of kissing stents configurations were often inferior to open repair. In 2013 the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) technique was introduced in an attempt to improve endovascular treatment results by a more anatomical and physiological reconstruction, with a subsequent improved clinical outcome.

This investigator-initiated multicenter trial will prospectively record all data on performed CERAB procedures using the Bentley balloon expandable covered stents (BeGraft Aortic and BeGraft Peripheral) in multiple International sites, in order to gain more robust real-world data on the efficacy of these stent grafts for this indication.

Consecutive patients in whom a CERAB will be performed with these particular covered stents in the participating centers.

Main study parameters/endpoints: The primary end-point of this study is technical success. Patency rates, peri-procedural morbidity, clinical improvement, quality of life, clinically-driven target vessel revascularization and reintervention-rate will be secondary outcome measures. Overall, patients will be followed for 5 years

Conditions

  • Aorto-Iliac Atherosclerosis
  • Aortoiliac Obstruction

Sponsors & Collaborators

  • Rijnstate Hospital

    lead OTHER

Principal Investigators

  • Michel Reijnen, MD, PhD · Principal Investigator

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-23
Primary Completion
2020-03-30
Completion
2020-03-30

Countries

  • Australia
  • Italy
  • Mexico
  • Netherlands
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03767686 on ClinicalTrials.gov