Ignite Creation Date:
2024-05-05 @ 11:35 PM
Last Modification Date:
2024-10-26 @ 10:36 AM
Study NCT ID:
NCT01368679
Status:
WITHDRAWN
Last Update Posted:
2014-11-19
First Post:
2011-06-06
Brief Title:
A Clinical Study to Evaluate the Safety and Performance of the Modular AAA Stent-Graft System
Sponsor:
Scitech Produtos Medicos Ltda
Organization:
Scitech Produtos Medicos Ltda
Study Overview
Official Title:
Phase III of the Prospective Non-randomized and Multicenter Clinical Evaluation of the Safety and Performance of the Modular AAA Stent-Graft System When Used in the Treatment of Subjects With Abdominal Aortic Aneurysms AAA
Status:
WITHDRAWN
Status Verified Date:
2014-11
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:
Stent-Graft
Brief Summary:
This is a prospective multicenter observational study with 20 patients to evaluate the performance of SCITECH stent for treatment of AAA Will be enrolled the patient demographics laboratory tests medical history clinical evaluation physical examination adverse events
The benefits and risks of the study should be explained before any specific test or procedure of the study The written consent must be obtained from the patient No action specifies the study should be performed while the patient has not signed the form of consent
The benefits and risks of the study should be explained before any specific test or procedure of the study The written consent must be obtained from the patient No action specifies the study should be performed while the patient has not signed the form of consent
Detailed Description:
Until the 90s the treatment of AAA was exclusively surgical presenting a significant risk of death however many patients could not undergo this surgery because of the invasive nature of the procedure
The mortality and comorbidity were associated with significant surgical repair of AAAs particularly in elderly patients with multiple medical problems Surgical complications were mainly associated with the surgical incision comorbidity presented by the patient changes cardiopulmonary and problems related to clotting of the patient The postoperative complications included bleeding renal failure paraplegy and the need for prolonged ventilatory support The literature shows that mortality rates for elective surgery is 0-61 with 27 as average
Due to the risks and complexities inherent in surgical procedures various devices and alternative methods have been proposed to treat aneurysms The method most used today is the implantation of stents through a delivery system This method is defined as minimally invasive to dispense the need for opening the abdominal cavity through large incisions and use a remote access common femoral artery or external iliac to introduce and deploy the device via an endovascular route
With technological progress have been developed many devices all with similar characteristics which are currently used in different countries Numerous devices are currently used to treat aneurysms
Over the past 10 years were developed and approved new stents however despite the advances that have represented the use of minimally invasive devices and evidence of improvement in indices of morbidity and mortality in the first six months there is still a need to improve results since the long-term endovascular treatment is equal to the conventional surgical treatment With the technological devices you can improve your long-term performance and obviate the need for dissection of the femoral vessels using thinner delivery devices that allow percutaneous introduction
The mortality and comorbidity were associated with significant surgical repair of AAAs particularly in elderly patients with multiple medical problems Surgical complications were mainly associated with the surgical incision comorbidity presented by the patient changes cardiopulmonary and problems related to clotting of the patient The postoperative complications included bleeding renal failure paraplegy and the need for prolonged ventilatory support The literature shows that mortality rates for elective surgery is 0-61 with 27 as average
Due to the risks and complexities inherent in surgical procedures various devices and alternative methods have been proposed to treat aneurysms The method most used today is the implantation of stents through a delivery system This method is defined as minimally invasive to dispense the need for opening the abdominal cavity through large incisions and use a remote access common femoral artery or external iliac to introduce and deploy the device via an endovascular route
With technological progress have been developed many devices all with similar characteristics which are currently used in different countries Numerous devices are currently used to treat aneurysms
Over the past 10 years were developed and approved new stents however despite the advances that have represented the use of minimally invasive devices and evidence of improvement in indices of morbidity and mortality in the first six months there is still a need to improve results since the long-term endovascular treatment is equal to the conventional surgical treatment With the technological devices you can improve your long-term performance and obviate the need for dissection of the femoral vessels using thinner delivery devices that allow percutaneous introduction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None