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.

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).

Study Overview

• Status: Completed
• Conditions: Aortic Aneurysm
• Intervention / Treatment: Device: pEVAR; Procedure: open femoral access

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1160
    • Wilhelminenspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Indication for endovascular aortic repair

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: pEVAR; percutaneous femoral access using a suture-mediated closure system	Device: pEVAR; percutaneous femoral access using a suture-mediated closure device
Active Comparator: open femoral access; cutdown to femoral artery and surgical closure	Procedure: open femoral access; cutdown to femoral artery and surgical closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound complications	Descriptive analysis of wound healing and complications after open vs. percutaneous access in the same individual.	up to 10 days postoperative

Collaborators and Investigators

• Sponsor: Wilhelminenspital Vienna
• Investigators: Study Director: Afshin Assadian, PD, MD, Wilhelminenspital Vienna

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: June 30, 2016
• First Submitted That Met QC Criteria: July 1, 2016
• First Posted (Estimate): July 4, 2016

Study Record Updates

• Last Update Posted (Actual): May 12, 2017
• Last Update Submitted That Met QC Criteria: May 11, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: cost analysis; Endovascular Aortic Repair (EVAR); percutaneous EVAR (pEVAR); procedure time
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm
• Other Study ID Numbers: 16-014-0216

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Patient characteristics (gender, age, body mass index, earlier operations, written wound documentation etc.), operation time, material and overall procedure costs.

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.: Yes