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Subclavian Artery Plug Embolization (SAPE)

S

San Donato Group (GSD)

Status

Completed

Conditions

Subclavian Artery Plug Embolization

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

150 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • adult patients aged ≥ 18 years,
  • patients candidates for endovascular treatment of subclavian artery occlusion with Amplatzer Vascular Plug

Exclusion criteria

• none

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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