Aorta AneurysmSPAINNCT04307888
Spanish Percutaneous Aortic INtervention REGISTRY (SPAIN REGISTRY)
An observational study of Aorta Aneurysm and Aorta Dissection, run by Sociedad Espanola de Angiologia y Cirugia Vascular.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aorta Aneurysm, Aorta Dissection, Aorta Stenosis
- What is being tested?
- Perclose Proglide (Abbott)
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Apr 2020to Mar 2022
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Aorta Aneurysm, Aorta Dissection, Aorta Stenosis, Aortic Coarctation, Aortic Rupture, Aortic Valve Disease
- Being tested
- Perclose Proglide (Abbott)
- Keywords
- Percutaneous access
- Medical subject headings
- Aortic Aneurysm, Aortic Dissection, Aortic Valve Stenosis, Aortic Coarctation, Aortic Rupture, Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perclose Proglide (Abbott)Device
Common Femoral Artery percutaneous access closure by means of Perclose Proglide device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Perclose Proglide (Abbott) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 30 days
Secondary outcomes (3)
Time of closure procedure hemostasis in seconds
Duration in seconds of the arterial closure procedure until complete hemostasis
Measured: 1 hour
Hospital Stay assessed in days
Duration in days until hospital discharge
Measured: 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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study startApr 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aorta AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Sociedad Espanola de Angiologia y Cirugia Vascular
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Teresa Hernandez Carbonell, MD, Study director, Hospital Quiron Salud MarbellaFrancisco J Medina, MD, Study director, Hospital Universitario BurgosIgnacio Agundez-Gomez, MD, Study director, Hospital Universitario Burgos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307888
- Sponsor's protocol ID
- RIV-2019-01
- Acronym
- SPAIN
- Status last verified
- Mar 2020
- First submitted
- 9 Mar 2020
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spanish Percutaneous Aortic INtervention REGISTRY (SPAIN REGISTRY)
- ClinicalTrials.gov ID
- NCT04307888
- Acronym / sponsor ID
- SPAIN / RIV-2019-01
- Conditions
- Aorta Aneurysm, Aorta Dissection, Aorta Stenosis, Aortic Coarctation, Aortic Rupture, Aortic Valve Disease
- Keywords
- Percutaneous access
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Sociedad Espanola de Angiologia y Cirugia VascularResearch network
- Study start
- Apr 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Device: Perclose Proglide (Abbott)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perclose Proglide (Abbott)Common Femoral Artery percutaneous access closure by means of Perclose Proglide device | Device | Study group |
Primary outcome
Rate of closure-procedure technical success as assessed by absence of femoral pseudoaneurysm or arterial occlusion
Time frame: 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
Time frame: 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)
Time frame: 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.
3 secondary outcomes
Time of closure procedure hemostasis in seconds
Time frame: 1 hour
Hospital Stay assessed in days
Time frame: 30 days
Post-operative Pain assessed by the Visual Analog Scale for Pain
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa Hernandez Carbonell, MD study director
Hospital Quiron Salud Marbella
Francisco J Medina, MD study director
Hospital Universitario Burgos
Ignacio Agundez-Gomez, MD study director
Hospital Universitario Burgos
Questions about this trial
What is this clinical trial studying?
An observational study of Aorta Aneurysm and Aorta Dissection, run by Sociedad Espanola de Angiologia y Cirugia Vascular.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joaquin De Haro, MD (+34 626022977, deharojoaquin@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of closure-procedure technical success as assessed by absence of femoral pseudoaneurysm or arterial occlusion (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2020.