Aortic AneurysmEVAccessNCT02822560
Economic Comparison of Percutaneous (pEVAR) vs. Open Access in EVAR.
A study testing pEVAR and open femoral access in people with Aortic Aneurysm, run by Wilhelminenspital Vienna at 1 site in Austria.
Trial summary
The present clinical trial is performed in the field of vascular surgery. The aim of the study is the economical and clinical comparison of two different access ways to the femoral artery with intention of endovascular repair of aortic aneurysm. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Aortic Aneurysm
- What is being tested?
- pEVAR and open femoral access
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2016to Feb 2017
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for endovascular aortic repair
Who cannot join
- femoral aneurysm, severe femoral artery calcification, keloided inguinal region, severe obesity, patients diagnosed with Alzheimer's disease or severe psychiatric diagnosis, patient's with occlusive aortic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Clinical and Economic Analysis of Percutaneous vs. Open Access for Endovascular Aortic Repair - a Prospective, Randomised Trial.
The present clinical trial is performed in the field of vascular surgery. The aim of the study is the economical and clinical comparison of two different access ways to the femoral artery with intention of endovascular repair of aortic aneurysm. The usual access is a surgical cutdown to the femoral artery and is compared to a percutaneous access which is closed via a suture mediated device (Perclose ProGlide, Abbott).
Read the detailed description
Introduction:
Endovascular repair of aortic aneurysms (EVAR) is a routine procedure in vascular surgery and associated with less perioperative complications compared to open aortic repair. Continuous improvement of endovascular techniques is crucial for sufficient patient care, especially in elderly with serious comorbidities. Percutaneous access (pEVAR) to the femoral artery is associated with less wound complications when performed in suitable patients. Prospective data about economic feasibility and exact duration of the technique itself compared to the open access during the surgery are missing.
Methods and data collection:
The primary endpoints of this prospective randomised single center trial are cost and time differences of open vs. percutaneous access. Each Patient enrolled in the study will receive percutaneous on one side and surgical access on the other side of the groin for femoral artery access.
The punction site will be closed using the Perclose ProGlide Suture-Mediated Closure System manufactured by Abbott Vascular. This device works through stiff wire guided delivering of a monofilament suture to the femoral artery punction site. After finishing endovascular procedures for aneurysm repair, the thereby laid sutures are tightened to achieve hemostasis. This system is suitable for sheath sizes up to 21 F (.28 inch).
Open access on the other side is performed with a cutdown to the femoral artery and closure after finished procedure, with a polypropylene suture.
Patients who undergo endovascular aortic repair at the Department of Vascular Surgery of Wilhelminenspital Vienna are recruited for the study after informed consent and fulfilled inclusion criteria. Included are men and women from the age of 18 - 90 years with any indication for endovascular aneurysm repair (thoracic, infrarenal aortic or iliac artery aneurysm, or combinations of these). Indication for aneurysm repair is not a part of this study and is set in accordance to international guidelines. Women in childbearing years could be included after detailed explanation of special risks for further pregnancy after EVAR and after proof of negative pregnancy test. Exclusion criteria are occlusive aortic disease, aneurysm of the femoral artery, diameter < 5mm or severe calcification, patients with keloided inguinal site, adipositas per magna or demented patients.
Due to a prior power analysis a optimum number of 50 cases was determined. Randomization is performed by lot (patients draw an envelope which contains either left or right side is done by pEVAR).
Data is collected preoperatively with a case report form (CRF) including detailed health information about the patient. During the surgery, femoral artery access and wound closure time is measured separately for each side (in minutes). Material costs are also documented separately for each side (in €). Postoperative data about wound healing and pain of each inguinal side are collected descriptive using the CRF. Data management and analysis is anonymous using random patient numbers on the forms.
Main targets of the study are cost and time difference of percutaneous and open access techniques. Possible difference in both groups will be analyzed using the Wilcoxon Signed Rank Test. Postoperative data will be evaluated descriptively.
In case of cost advantage of the percutaneous access, this study economically legitimates the use of suture mediated closure systems and therefore contributes to the establishment of minimally invasive endovascular aortic repair.
- Conditions
- Aortic Aneurysm
- Being tested
- pEVAR, open femoral access
- Keywords
- Endovascular Aortic Repair (EVAR), percutaneous EVAR (pEVAR), cost analysis, procedure time
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pEVARDevice
percutaneous femoral access using a suture-mediated closure device
open femoral accessProcedure or surgery
cutdown to femoral artery and surgical closure
| Study group | Role | What they receive |
|---|---|---|
| pEVAR | Active comparator | percutaneous femoral access using a suture-mediated closure system Receives: Device: pEVAR |
| open femoral access | Active comparator | cutdown to femoral artery and surgical closure Receives: Procedure: open femoral access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall costs of each different access
Overall costs of each different access way including used material and duration of the procedure (shorter duration = less costs of running operation theatre).
Measured: During surgery
Secondary outcomes (1)
Access duration
Separately measured duration of each access way itself (from start until first sheath is applied and from removal of sheath until wound is closed). The duration of endovascular repair is not included.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wilhelminenspital Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miriam Uhlmann, Wilhelminenspital Vienna
- Investigators
- Afshin Assadian, PD, MD, Study director, Wilhelminenspital Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822560
- Sponsor's protocol ID
- 16-014-0216
- Acronym
- EVAccess
- Status last verified
- May 2017
- First submitted
- 30 Jun 2016
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Patient characteristics (gender, age, body mass index, earlier operations, written wound documentation etc.), operation time, material and overall procedure costs.
Publications
Uhlmann ME, Walter C, Taher F, Plimon M, Falkensammer J, Assadian A. Successful percutaneous access for endovascular aneurysm repair is significantly cheaper than femoral cutdown in a prospective randomized trial. J Vasc Surg. 2018 Aug;68(2):384-391. doi: 10.1016/j.jvs.2017.12.052. Epub 2018 Mar 8.
PubMed 29526378
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical and Economic Analysis of Percutaneous vs. Open Access for Endovascular Aortic Repair - a Prospective, Randomised Trial.
- ClinicalTrials.gov ID
- NCT02822560
- Acronym / sponsor ID
- EVAccess / 16-014-0216
- Conditions
- Aortic Aneurysm
- Keywords
- Endovascular Aortic Repair (EVAR), percutaneous EVAR (pEVAR), cost analysis, procedure time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Wilhelminenspital ViennaUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 4 Jul 2016 (estimated)
- 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.
The present clinical trial is performed in the field of vascular surgery. The aim of the study is the economical and clinical comparison of two different access ways to the femoral artery with intention of endovascular repair of aortic aneurysm. The usual access is a surgical cutdown to the femoral artery and is compared to a percutaneous access which is closed via a suture mediated device (Perclose ProGlide, Abbott).
Detailed description
Introduction:
Endovascular repair of aortic aneurysms (EVAR) is a routine procedure in vascular surgery and associated with less perioperative complications compared to open aortic repair. Continuous improvement of endovascular techniques is crucial for sufficient patient care, especially in elderly with serious comorbidities. Percutaneous access (pEVAR) to the femoral artery is associated with less wound complications when performed in suitable patients. Prospective data about economic feasibility and exact duration of the technique itself compared to the open access during the surgery are missing.
Methods and data collection:
The primary endpoints of this prospective randomised single center trial are cost and time differences of open vs. percutaneous access. Each Patient enrolled in the study will receive percutaneous on one side and surgical access on the other side of the groin for femoral artery access.
The punction site will be closed using the Perclose ProGlide Suture-Mediated Closure System manufactured by Abbott Vascular. This device works through stiff wire guided delivering of a monofilament suture to the femoral artery punction site. After finishing endovascular procedures for aneurysm repair, the thereby laid sutures are tightened to achieve hemostasis. This system is suitable for sheath sizes up to 21 F (.28 inch).
Open access on the other side is performed with a cutdown to the femoral artery and closure after finished procedure, with a polypropylene suture.
Patients who undergo endovascular aortic repair at the Department of Vascular Surgery of Wilhelminenspital Vienna are recruited for the study after informed consent and fulfilled inclusion criteria. Included are men and women from the age of 18 - 90 years with any indication for endovascular aneurysm repair (thoracic, infrarenal aortic or iliac artery aneurysm, or combinations of these). Indication for aneurysm repair is not a part of this study and is set in accordance to international guidelines. Women in childbearing years could be included after detailed explanation of special risks for further pregnancy after EVAR and after proof of negative pregnancy test. Exclusion criteria are occlusive aortic disease, aneurysm of the femoral artery, diameter < 5mm or severe calcification, patients with keloided inguinal site, adipositas per magna or demented patients.
Due to a prior power analysis a optimum number of 50 cases was determined. Randomization is performed by lot (patients draw an envelope which contains either left or right side is done by pEVAR).
Data is collected preoperatively with a case report form (CRF) including detailed health information about the patient. During the surgery, femoral artery access and wound closure time is measured separately for each side (in minutes). Material costs are also documented separately for each side (in €). Postoperative data about wound healing and pain of each inguinal side are collected descriptive using the CRF. Data management and analysis is anonymous using random patient numbers on the forms.
Main targets of the study are cost and time difference of percutaneous and open access techniques. Possible difference in both groups will be analyzed using the Wilcoxon Signed Rank Test. Postoperative data will be evaluated descriptively.
In case of cost advantage of the percutaneous access, this study economically legitimates the use of suture mediated closure systems and therefore contributes to the establishment of minimally invasive endovascular aortic repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pEVAR | Active comparator | Device: pEVARpercutaneous femoral access using a suture-mediated closure system |
| open femoral access | Active comparator | Procedure: open femoral accesscutdown to femoral artery and surgical closure |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Indication for endovascular aortic repair
Key exclusion criteria (1 listed)
- femoral aneurysm, severe femoral artery calcification, keloided inguinal region, severe obesity, patients diagnosed with Alzheimer's disease or severe psychiatric diagnosis, patient's with occlusive aortic disease
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 |
|---|---|---|
| pEVARpercutaneous femoral access using a suture-mediated closure device | Device | pEVAR |
| open femoral accesscutdown to femoral artery and surgical closure | Procedure or surgery | open femoral access |
Primary outcome
Overall costs of each different access
Time frame: During surgery
Overall costs of each different access way including used material and duration of the procedure (shorter duration = less costs of running operation theatre).
1 secondary outcome
Access duration
Time frame: During surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Derived from this study: PubMed 29526378Uhlmann ME, Walter C, Taher F, Plimon M, Falkensammer J, Assadian A. Successful percutaneous access for endovascular aneurysm repair is significantly cheaper than femoral cutdown in a prospective randomized trial. J Vasc Surg. 2018 Aug;68(2):384-391. doi: 10.1016/j.jvs.2017.12.052. Epub 2018 Mar 8.
- Individual participant dataSharing planned: Undecided. Patient characteristics (gender, age, body mass index, earlier operations, written wound documentation etc.), operation time, material and overall procedure costs.
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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.
Afshin Assadian, PD, MD study director
Wilhelminenspital Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pEVAR and open femoral access in people with Aortic Aneurysm, run by Wilhelminenspital Vienna at 1 site in Austria.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall costs of each different access (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02822560, which also lists 1 linked publication.
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 12 May 2017.