Subclavian Artery Plug Embolization (SAPE)

Completed

• Conditions: Subclavian Artery Plug Embolization

• Registration Number: NCT03620006
• Lead Sponsor: IRCCS San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-21
• Study Start: 2018-05-22
• Study First Submitted QC: 2018-08-02
• Study First Posted: 2018-08-08
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-10
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

San Raffaele Hospital; 🇮🇹 Milano, Italy