Subclavian Artery Plug Embolization (SAPE)

Endovascular Occlusion by Plug of the Prevertebral Subclavian Artery Preparatory to the Surgical or Endovascular Aortic Procedures (SAPE)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03620006

Acronym

SAPE

Enrollment

150

Registered

2018-08-08

Start date

2018-05-22

Completion date

2022-03-31

Last updated

2022-11-14

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

Conditions

Subclavian Artery Plug Embolization

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Technical success rate	within 30-day	Technical success rate defined as complete occlusion of the left subclavian artery at postoperative CT scan
Major adverse event rate	within 30-day	Any stroke or mortality related to the surgical procedure

Secondary

Measure	Time frame	Description
Supra-aortic vessels patency rate	within 5-years	Patency of the carotid and subaclavian artery at follow-up
Access site complications requiring secondary adjunctive procedures	within 30-day	Any access site complication requiring open or endovascular adjuctive procedures (ie: surgical embolectomy, echo-guided pseudoaneurysm manual compression)

Countries

Italy

Outcome results