Subclavian Artery Plug Embolization Clinical Trial
— SAPEOfficial title:
Endovascular Occlusion by Plug of the Prevertebral Subclavian Artery Preparatory to the Surgical or Endovascular Aortic Procedures (SAPE)
| NCT number | NCT03620006 |
| Other study ID # | SAPE |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 22, 2018 |
| Est. completion date | March 31, 2022 |
| Verified date | November 2022 |
| Source | IRCCS San Raffaele |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | March 31, 2022 |
| Est. primary completion date | March 31, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - adult patients aged = 18 years, - patients candidates for endovascular treatment of subclavian artery occlusion with Amplatzer Vascular Plug Exclusion Criteria: • none |
| Country | Name | City | State |
|---|---|---|---|
| Italy | San Raffaele Hospital | Milano |
| Lead Sponsor | Collaborator |
|---|---|
| IRCCS San Raffaele |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Technical success rate | Technical success rate defined as complete occlusion of the left subclavian artery at postoperative CT scan | within 30-day | |
| Primary | Major adverse event rate | Any stroke or mortality related to the surgical procedure | within 30-day | |
| Secondary | 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) | within 30-day | |
| Secondary | Supra-aortic vessels patency rate | Patency of the carotid and subaclavian artery at follow-up | within 5-years |