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OpenTrials
Completed

NCT Number: NCT03620006

Subclavian Artery Plug Embolization (SAPE)

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.

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Key information

Conditions

Subclavian Artery Plug Embolization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

San Raffaele Hospital

Milan, 20132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. Technical success rate

    Time frame: within 30-day

    Technical success rate defined as complete occlusion of the left subclavian artery at postoperative CT scan

  2. Major adverse event rate

    Time frame: within 30-day

    Any stroke or mortality related to the surgical procedure

Secondary outcomes

  1. Access site complications requiring secondary adjunctive procedures

    Time frame: within 30-day

    Any access site complication requiring open or endovascular adjuctive procedures (ie: surgical embolectomy, echo-guided pseudoaneurysm manual compression)

  2. Supra-aortic vessels patency rate

    Time frame: within 5-years

    Patency of the carotid and subaclavian artery at follow-up

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Acronym: SAPE

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 8, 2018
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.