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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoprothesis Scitech | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoprothesis Implantation | Procedure | stent implantation in the abdominal artery using endovascular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Adverse Events |
| Adverse Events |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation the performance of the stent delivery system | Evaluate the performance of the stent delivery system:
| Performance of stent-grift |
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Inclusion Criteria:
Age greater than or equal to 18 years
Concordance of the patient through the end of a written consent form approved by the local Ethics Committee;
Proximal colon with the following characteristics: the intima to intima diameter of 16 to 30mm; Length of the proximal neck greater than 8mm angulation of the aorta justarenal less than or equal to 60 degrees.
Iliac axes: the distal neck length greater than 10mm; the intima to intima diameter between 7 and 20mm.
Present at least one of the following:
Patient who has access to the iliac or femoral artery for stent implantation in the abdominal aorta.
The patient is able to meet the follow-up examination in 30 days, 180 days and 360 days.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Álvaro Razuk, Medicine | Irmandade da Santa Casa de Misericórdia de São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Caridade | São Francisco do Sul | Santa Catarina | 89240-000 | Brazil | ||
| Irmandade da Santa Casa de Misericórdia de São Paulo |
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| Label | URL |
|---|---|
| Site sponsor | View source |
| Site about the location that will be done the study. Location where the principal investigator works. | View source |
| National Information System on Ethics in Research involving Human |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D001018 | Aortic Diseases |
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| ID | Term |
|---|---|
| D015607 | Stents |
| D057510 | Endovascular Procedures |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
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| São Paulo |
| São Paulo |
| 01221-020 |
| Brazil |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |