Economic Comparison of Percutaneous (pEVAR) vs. Open Access in EVAR.
Condition: Aortic Aneurysm
MeSH terms: Aneurysm; Aortic Aneurysm
Study type: Interventional

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).
    

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.
    

Intervention name(s): pEVAR; open femoral access
Intervention type(s): Device; Procedure
Intervention description(s): percutaneous femoral access using a suture-mediated closure device; cutdown to femoral artery and surgical closure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Endovascular Aortic Repair (EVAR); percutaneous EVAR (pEVAR); cost analysis; procedure time