Spanish Percutaneous Aortic INtervention REGISTRY (SPAIN REGISTRY)

Sponsor

Sociedad Espanola de Angiologia y Cirugia Vascular (Other)

Overall Status

Unknown status

CT.gov ID

NCT04307888

Collaborator

(none)

600

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aorta Aneurysm Aorta Dissection Aorta Stenosis Aortic Coarctation Aortic Rupture Aortic Valve Disease Aortic Valve Stenosis	Device: Perclose Proglide (Abbott)

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

600 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Spanish Percutaneous Aortic INtervention REGISTRY (SPAIN REGISTRY)

Anticipated Study Start Date :

Apr 1, 2020

Anticipated Primary Completion Date :

Mar 1, 2021

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: Perclose Proglide (Abbott) Common Femoral Artery percutaneous access closure by means of Perclose Proglide device

Arm

Intervention/Treatment

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.

Device: Perclose Proglide (Abbott)

Common Femoral Artery percutaneous access closure by means of Perclose Proglide device

Outcome Measures

Primary Outcome Measures

Rate of closure-procedure technical success as assessed by absence of femoral pseudoaneurysm or arterial occlusion [30 days]
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.
Quality of Life assesed by EuroQol-5 Dimensions (EQ-5D) Questionnaire [30 days]
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).
Incidence of Procedure-Emergent Adverse Events related to Frailty as assessed by the Modified Frailty Index (mFI-11) [30 days]
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.

Secondary Outcome Measures

Time of closure procedure hemostasis in seconds [1 hour]
Duration in seconds of the arterial closure procedure until complete hemostasis
Hospital Stay assessed in days [30 days]
Duration in days until hospital discharge
Post-operative Pain assessed by the Visual Analog Scale for Pain [30 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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