Spanish Percutaneous Aortic INtervention REGISTRY (SPAIN REGISTRY) (SPAIN)

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.

Study Overview

• Status: Unknown
• Conditions: Aortic Valve Stenosis; Aortic Valve Disease; Aortic Coarctation; Aortic Rupture; Aorta Dissection; Aorta Aneurysm; Aorta Stenosis
• Intervention / Treatment: Device: Perclose Proglide (Abbott)

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of closure procedure hemostasis in seconds	Duration in seconds of the arterial closure procedure until complete hemostasis	1 hour
Hospital Stay assessed in days	Duration in days until hospital discharge	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.	30 days

Collaborators and Investigators

• Sponsor: Sociedad Espanola de Angiologia y Cirugia Vascular
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2020
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: March 12, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 23, 2020
• Last Update Submitted That Met QC Criteria: March 19, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Percutaneous access
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Wounds and Injuries; Congenital Abnormalities; Pathological Conditions, Anatomical; Heart Valve Diseases; Ventricular Outflow Obstruction; Heart Defects, Congenital; Cardiovascular Abnormalities; Aneurysm; Aortic Diseases; Aortic Aneurysm; Aneurysm, Ruptured; Aortic Valve Stenosis; Rupture; Constriction, Pathologic; Aortic Valve Disease; Aortic Coarctation; Aortic Rupture
• Other Study ID Numbers: RIV-2019-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No