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Subclavian Artery Plug Embolization (SAPE)

NCT03620006 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2022-11-14

No results posted yet for this study

Summary

This is an observational, no-profit, ambispective study: a retrospective arm will include the cases treated between August 2009 and March 2018, and a prospective arm, investigating patients treated from March 2018 until December 2018. Target study population size is 150 patients between two groups analyzed.

Endovascular occlusion of the prevertebral subclavian artery was first used in the Vascular Surgery Department at San Raffaele Hospital in August 2009. During the initial experience (2009-2014) this technique was used with low frequency. Since 2015, the volume of cases receiving this treatment, has increased and the investigators expect to reach the study population target, by the end of 2018.

The objective of this study is describe the casuistry of endovascular occlusion of the subclavian artery by means of the Amplatzer Vascular plug in the Vascular Surgery Department at San Raffaele Hospital, and to evaluate the efficacy of such procedure.

Moreover, the investigators will evaluate the patency and success rate of the carotid-subclavian bypasses performed at the same time of the analyzed procedure.

Conditions

  • Subclavian Artery Plug Embolization

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-22
Primary Completion
2022-03-31
Completion
2022-03-31

Countries

  • Italy

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 NCT03620006 on ClinicalTrials.gov