Subclavian Artery Plug Embolization (SAPE)

NCT ID: NCT03620006

Last Updated: 2022-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-22

Study Completion Date

2022-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Subclavian Artery Plug Embolization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

• none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Bertoglio Luca

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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San Raffaele Hospital

Milan, , Italy

Site Status

Countries

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Italy

References

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Bertoglio L, Salvati S, Fittipaldi A, Melloni A, Kahlberg A, Cambiaghi T, Melissano G, Chiesa R. Carotid to subclavian bypass and Amplatzer vascular plug subclavian endovascular occlusion before thoracic open or endovascular repair. J Vasc Surg. 2020 May;71(5):1480-1488.e1. doi: 10.1016/j.jvs.2019.08.237. Epub 2019 Oct 17.

Reference Type DERIVED
PMID: 31630886 (View on PubMed)

Other Identifiers

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SAPE

Identifier Type: -

Identifier Source: org_study_id

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