Peri-operative Mortality Clinical Trial
Official title:
Mortality and Complications in Endovascular Procedures Performed With New Generation Low-profile Devices
| NCT number | NCT04016545 |
| Other study ID # | 30027/19 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 1, 2019 |
| Est. completion date | August 1, 2021 |
The aim of this study is to observe mortality and complications in procedures in which are used new generation low-profile endoprothesis.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | August 1, 2021 |
| Est. primary completion date | August 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Patients with indications for elective TEVAR Exclusion Criteria: - Incapability to provide consent - Patients not eligible for TEVAR - Pregnancy |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Fondazione Policlinico Universitario A. Gemelli IRCCS | Roma | RM |
| Lead Sponsor | Collaborator |
|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mortality | Post-operative mortality (intra-operatory and up to 30 days post-surgery) | 30 days | |
| Secondary | Complications | Complications during follow-up | 24 months |
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|---|---|---|---|
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