A Clinical Study to Evaluate the Safety and Performance of the Modular AAA Stent-Graft System (Stent-Graft)
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.
|Cardiovascular Diseases Abdominal Aortic Aneurysm||Procedure: Endoprothesis Implantation||Phase 3|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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)|
- Evaluation of Adverse Events [ Time Frame: Adverse Events ]
- Evaluate the serious adverse events at 30 days after the implant the stent.
- Evaluate safety of this stent for treatment of AAA after 30, 180 and 360 days implant.
- Evaluation the performance of the stent delivery system [ Time Frame: Performance of stent-grift ]
Evaluate the performance of the stent delivery system:
- Successful delivery of the stent in the abdominal aorta and exclusion or treatment of abdominal aortic aneurysm.
- follow endoleaks type I, III and IV after 30, 180, and 360 days.
- Incidence of major adverse events at 180 and 360 days after implantation or at any time.
Experimental: Endoprothesis Scitech
The endoprothesis of SCITECH is a self-expandable stent mixed (laser cut and wire plotted) covered with polyester fabric. The delivery system has lower profile than the existing market and this approach allows the passage of the delivery system through the femoral artery with ease and without dissection. Fixation has proximal and distal securing lower rates of leakage and displacement.
The delivery system is done by linear drive or screw diameters greater than 30mm
Procedure: Endoprothesis Implantation
stent implantation in the abdominal artery using endovascular
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 0-6.1%, with 2.7% 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368679
|Hospital de Caridade|
|São Francisco do Sul, Santa Catarina, Brazil, 89240-000|
|Irmandade da Santa Casa de Misericórdia de São Paulo|
|São Paulo, Brazil, 01221-020|
|Principal Investigator:||Álvaro Razuk, Medicine||Irmandade da Santa Casa de Misericórdia de São Paulo|