Subclavian Artery Plug EmbolizationSAPENCT03620006
Subclavian Artery Plug Embolization (SAPE)
An observational study of Subclavian Artery Plug Embolization, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subclavian Artery Plug Embolization
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 22 May 2018to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients aged ≥ 18 years, candidates for endovascular treatment of subclavian artery occlusion with Amplatzer Vascular Plug
Who may be able to join
- adult patients aged ≥ 18 years,
- patients candidates for endovascular treatment of subclavian artery occlusion with Amplatzer Vascular Plug
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endovascular Occlusion by Plug of the Prevertebral Subclavian Artery Preparatory to the Surgical or Endovascular Aortic Procedures (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.
Read more
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success rate
Technical success rate defined as complete occlusion of the left subclavian artery at postoperative CT scan
Measured: within 30-day
Major adverse event rate
Any stroke or mortality related to the surgical procedure
Measured: within 30-day
Secondary outcomes (2)
Access site complications requiring secondary adjunctive procedures
Any access site complication requiring open or endovascular adjuctive procedures (ie: surgical embolectomy, echo-guided pseudoaneurysm manual compression)
Measured: within 30-day
Supra-aortic vessels patency rate
Patency of the carotid and subaclavian artery at follow-up
Measured: within 5-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start22 May 2018
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subclavian Artery Plug EmbolizationStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bertoglio Luca, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620006
- Sponsor's protocol ID
- SAPE
- Acronym
- SAPE
- Status last verified
- Nov 2022
- First submitted
- 21 May 2018
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31630886
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Occlusion by Plug of the Prevertebral Subclavian Artery Preparatory to the Surgical or Endovascular Aortic Procedures (SAPE)
- ClinicalTrials.gov ID
- NCT03620006
- Acronym / sponsor ID
- SAPE / SAPE
- Conditions
- Subclavian Artery Plug Embolization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 22 May 2018 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients aged ≥ 18 years, candidates for endovascular treatment of subclavian artery occlusion with Amplatzer Vascular Plug
Key inclusion criteria (2 listed)
- adult patients aged ≥ 18 years,
- patients candidates for endovascular treatment of subclavian artery occlusion with Amplatzer Vascular Plug
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Technical success rate
Time frame: within 30-day
Technical success rate defined as complete occlusion of the left subclavian artery at postoperative CT scan
Major adverse event rate
Time frame: within 30-day
Any stroke or mortality related to the surgical procedure
2 secondary outcomes
Access site complications requiring secondary adjunctive procedures
Time frame: within 30-day
Supra-aortic vessels patency rate
Time frame: within 5-years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Derived from this study: PubMed 31630886Bertoglio 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subclavian Artery Plug Embolization, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success rate (time frame: within 30-day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03620006, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.