Spanish Percutaneous Aortic INtervention REGISTRY (SPAIN REGISTRY)
SPAIN
1 other identifier
observational
600
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2020
CompletedFirst Posted
Study publicly available on registry
March 13, 2020
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedMarch 23, 2020
March 1, 2020
11 months
March 9, 2020
March 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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).
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.
30 days
Secondary Outcomes (3)
Time of closure procedure hemostasis in seconds
1 hour
Hospital Stay assessed in days
30 days
Post-operative Pain assessed by the Visual Analog Scale for Pain
30 days
Study Arms (1)
Study group
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.
Interventions
Common Femoral Artery percutaneous access closure by means of Perclose Proglide device
Eligibility Criteria
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.
You may qualify if:
- Men and women over 18 years old
- Signed informed consent
- Endovascular procedures on the aorta to any level, performed by percutaneous access and requiring the use of devices ≥ 10F
- Femoral Access suitable for percutaneous treatment in the opinion of the surgeon
You may not qualify if:
- Need for surgical repair of the femoral artery (stenosis aneurysmal)
- Initial indication of percutaneous closure with another device different from the Perclose Proglide
- Active infection of the puncture site
- Condition that prevents complete the 30 days follow up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Teresa Hernandez Carbonell, MD
Hospital Quiron Salud Marbella
- STUDY DIRECTOR
Francisco J Medina, MD
Hospital Universitario Burgos
- STUDY DIRECTOR
Ignacio Agundez-Gomez, MD
Hospital Universitario Burgos
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 30 Days
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2020
First Posted
March 13, 2020
Study Start
April 1, 2020
Primary Completion
March 1, 2021
Study Completion
March 1, 2022
Last Updated
March 23, 2020
Record last verified: 2020-03