Clinical trial NCT04307888: Spanish Percutaneous Aortic INtervention REGISTRY (SPAIN REGISTRY)
Official title: Spanish Percutaneous Aortic INtervention REGISTRY (SPAIN REGISTRY)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aorta Aneurysm
Aorta Dissection
Aorta Stenosis
Aortic Coarctation
Aortic Rupture
Aortic Valve Disease
Aortic Valve Stenosis
Keywords: Percutaneous access
Lead sponsor: Sociedad Espanola de Angiologia y Cirugia Vascular
Sponsor class: NETWORK
First posted: 2020-03-13
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Rate of closure-procedure technical success as assessed by absence of femoral pseudoaneurysm or arterial occlusion
timeFrame: 30 days
measure: Quality of Life assesed by EuroQol-5 Dimensions (EQ-5D) Questionnaire
timeFrame: 30 days
measure: Incidence of Procedure-Emergent Adverse Events related to Frailty as assessed by the Modified Frailty Index (mFI-11)
timeFrame: 30 days
Secondary outcomes:
measure: Time of closure procedure hemostasis in seconds
timeFrame: 1 hour
measure: Hospital Stay assessed in days
timeFrame: 30 days
measure: Post-operative Pain assessed by the Visual Analog Scale for Pain
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Quiron Salud Marbella
name: Teresa Hernandez Carbonell, MD
role: STUDY_DIRECTOR
affiliation: Hospital Universitario Burgos
name: Francisco J Medina, MD
role: STUDY_DIRECTOR
affiliation: Hospital Universitario Burgos
name: Ignacio Agundez-Gomez, MD
role: STUDY_DIRECTOR
References: