Economic Comparison of Percutaneous (pEVAR) vs. Open Access in EVAR.
EVAccess
Comparative Clinical and Economic Analysis of Percutaneous vs. Open Access for Endovascular Aortic Repair - a Prospective, Randomised Trial.
1 other identifier
interventional
50
1 country
1
Brief 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. 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedFirst Posted
Study publicly available on registry
July 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedMay 12, 2017
May 1, 2017
7 months
June 30, 2016
May 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
During surgery
Secondary Outcomes (1)
Access duration
During surgery
Other Outcomes (1)
Wound complications
up to 10 days postoperative
Study Arms (2)
pEVAR
ACTIVE COMPARATORpercutaneous femoral access using a suture-mediated closure system
open femoral access
ACTIVE COMPARATORcutdown to femoral artery and surgical closure
Interventions
Eligibility Criteria
You may qualify if:
- Indication for endovascular aortic repair
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wilhelminenspital
Vienna, 1160, Austria
Related Publications (1)
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.
PMID: 29526378DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Afshin Assadian, PD, MD
Wilhelminenspital Vienna
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
June 30, 2016
First Posted
July 4, 2016
Study Start
July 1, 2016
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
May 12, 2017
Record last verified: 2017-05