An observational study in Aorta Aneurysm, Aorta Dissection and Aorta Stenosis, sponsored by Sociedad Espanola de Angiologia y Cirugia Vascular. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-23.
Sponsored by Sociedad Espanola de Angiologia y Cirugia Vascular · Observational
Multicentre prospective registry including consecutive patients undergoing Percutaneous Endovascular Aneurysm Repair (PEVAR), Percutaneous Endovascular Thoracic Aneurysm Repair (PTEVAR) or Transcatheter Aortic Valve Implantation (TAVI) in which variables related to the percutaneous access closure for implanting devices at aorta level will be collected and analyzed.
The follow-up period will be 30 days after the procedure. The duration of the recruitment period will be one year. All data will be collected telematically and incorporated into a database for subsequent statistical analysis.
There will be 2 points for data interim analysis at 6 and 12 months after initiation of the study.
222 studies on the registry are indexed under Aortic Aneurysm; 63 are open to participants now.
This study's planned enrollment of 600 is above the median of 150 across 117 observational studies indexed under Aortic Aneurysm.
Browse Aortic Aneurysm studies →Sociedad Espanola de Angiologia y Cirugia Vascular is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing Percutaneous Endovascular Aneurysm Repair (PEVAR), Percutaneous Endovascular Thoracic Aneurysm Repair (PTEVAR) or Transcatheter Aortic Valve Implantation (TAVI) in who percutaneous access closure device is used for implanting devices at aorta level.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing Percutaneous Endovascular Aneurysm Repair (PEVAR), Percutaneous Endovascular Thoracic Aneurysm Repair (PTEVAR) or Transcatheter Aortic Valve Implantation (TAVI) in who percutaneous access closure device is used for implanting devices at aorta level.
Device: Perclose Proglide (Abbott)
Common Femoral Artery percutaneous access closure by means of Perclose Proglide device
Rate of closure-procedure technical success as assessed by absence of femoral pseudoaneurysm or arterial occlusion
Rate of cases that are reported with a femoral pseudoaneurysm in the site of arterial access or common femoral artery occlusion related to the closure procedure.
Time frame: 30 days
Quality of Life assesed by EuroQol-5 Dimensions (EQ-5D) Questionnaire
Estimated Impact of the procedure on the Quality of Life measured by EQ-5D Questionnaire on 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. The study participants self-rate their level of severity for each dimension. Rated level can be coded as 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).
Time frame: 30 days
Incidence of Procedure-Emergent Adverse Events related to Frailty as assessed by the Modified Frailty Index (mFI-11)
Incidence of any postoperative adverse event or mortality related to the frailty assessed by the modified frailty index (mFI-11), an 11-factor score predictive of increased risk for postoperative morbidity and mortality in patients undergoing elective and emergent surgery that scores the frailty between 1 to 11, being the 11 the most frailty status.
Time frame: 30 days
Time of closure procedure hemostasis in seconds
Duration in seconds of the arterial closure procedure until complete hemostasis
Time frame: 1 hour
Hospital Stay assessed in days
Duration in days until hospital discharge
Time frame: 30 days
Post-operative Pain assessed by the Visual Analog Scale for Pain
Evaluation of the discomfort or pain after the procedure determined at the end of the procedure with the Visual Analog Scale for Pain, which is a psychometric measuring instrument designed to assess the pain intensity experienced by each patient individually. The analogous visual scale used for this study measures from 0-10 the intensity of the pain with a series of "faces" that show the intensity in the pain experimentation with categories like "No pain" approximately 0-1, mild, annoying in number 2, nagging in number 4, distressing in number 6, intense in number 8 and worst possible in number 10.
Time frame: 30 days
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Apr 2020; primary completion for Mar 2021, 11 months later.
Of 44 observational studies under Aortic Aneurysm, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 107. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Sociedad Espanola de Angiologia y Cirugia Vascular