Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-31 @ 9:49 PM
Study NCT ID:
NCT02822560
Status:
COMPLETED
Last Update Posted:
2017-05-12
First Post:
2016-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Economic Comparison of Percutaneous (pEVAR) vs. Open Access in EVAR.
Sponsor:
Wilhelminenspital Vienna
Organization:
Study Overview
Official Title:
Comparative Clinical and Economic Analysis of Percutaneous vs. Open Access for Endovascular Aortic Repair - a Prospective, Randomised Trial.
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVAccess
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).
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: