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出境医 / 临床实验 / Mortality and Complications in Endovascular Procedures Performed With New Generation Low-profile Devices
Mortality and Complications in Endovascular Procedures Performed With New Generation Low-profile Devices
Study Description
Brief Summary:
The aim of this study is to observe mortality and complications in procedures in which are used new generation low-profile endoprothesis.
| Condition or disease | Intervention/treatment |
|---|---|
| Peri-operative Mortality | Device: Low profile endoprothesis (Navion Medtronic, NBS Low Profile Bolton Terumo) |
Study Design
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 200 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Other |
| Target Follow-Up Duration: | 24 Months |
| Official Title: | Mortality and Complications in Endovascular Procedures Performed With New Generation Low-profile Devices |
| Actual Study Start Date : | October 1, 2019 |
| Estimated Primary Completion Date : | August 1, 2020 |
| Estimated Study Completion Date : | August 1, 2021 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
| Treated patients |
Device: Low profile endoprothesis (Navion Medtronic, NBS Low Profile Bolton Terumo)
Aortic aneurysm exclusion through endovascular procedure
|
Outcome Measures
Primary Outcome Measures :
- Mortality [ Time Frame: 30 days ]Post-operative mortality (intra-operatory and up to 30 days post-surgery)
Secondary Outcome Measures :
- Complications [ Time Frame: 24 months ]Complications during follow-up
Eligibility Criteria
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients eligible for elective TEVAR treatable with low-profile endoprothesis
Criteria
Inclusion Criteria:
- Patients with indications for elective TEVAR
Exclusion Criteria:
- Incapability to provide consent
- Patients not eligible for TEVAR
- Pregnancy
Contacts and Locations
Contacts
| Contact: Giovanni Tinelli | 0039 0630157205 | giovanni.tinelli@policlinicogemelli.it |
Locations
| Italy | |
| Fondazione Policlinico Universitario A. Gemelli IRCCS | Recruiting |
| Roma, RM, Italy, 00167 | |
| Contact: Giovanni Tinelli 0039 0630157205 giovanni.tinelli@policlinicogemelli.it | |
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | July 9, 2019 | ||||
| First Posted Date | July 11, 2019 | ||||
| Last Update Posted Date | February 6, 2020 | ||||
| Actual Study Start Date | October 1, 2019 | ||||
| Estimated Primary Completion Date | August 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Mortality [ Time Frame: 30 days ] Post-operative mortality (intra-operatory and up to 30 days post-surgery)
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
Complications [ Time Frame: 24 months ] Complications during follow-up
|
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Mortality and Complications in Endovascular Procedures Performed With New Generation Low-profile Devices | ||||
| Official Title | Mortality and Complications in Endovascular Procedures Performed With New Generation Low-profile Devices | ||||
| Brief Summary | The aim of this study is to observe mortality and complications in procedures in which are used new generation low-profile endoprothesis. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational [Patient Registry] | ||||
| Study Design | Observational Model: Case-Only Time Perspective: Other |
||||
| Target Follow-Up Duration | 24 Months | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients eligible for elective TEVAR treatable with low-profile endoprothesis | ||||
| Condition | Peri-operative Mortality | ||||
| Intervention | Device: Low profile endoprothesis (Navion Medtronic, NBS Low Profile Bolton Terumo)
Aortic aneurysm exclusion through endovascular procedure
|
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| Study Groups/Cohorts | Treated patients
Intervention: Device: Low profile endoprothesis (Navion Medtronic, NBS Low Profile Bolton Terumo)
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
200 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | August 1, 2021 | ||||
| Estimated Primary Completion Date | August 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| Listed Location Countries | Italy | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04016545 | ||||
| Other Study ID Numbers | 30027/19 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Dr. Tinelli, Fondazione Policlinico Universitario Agostino Gemelli IRCCS | ||||
| Study Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | ||||
| Verification Date | February 2020 | ||||
