NCT03620006

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
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2018-05-22
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2018-08-08
• Last updated: 2022-11-14

Locations

1 site across 1 country: Italy