Brief Title
A Clinical Study to Evaluate the Safety and Performance of the Modular AAA Stent-Graft System
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)
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.
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
0-6.1%, 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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Evaluation of Adverse Events
Secondary Outcome
Evaluation the performance of the stent delivery system
Condition
Cardiovascular Diseases
Intervention
Endoprothesis Implantation
Study Arms / Comparison Groups
Endoprothesis Scitech
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
0
Eligibility Criteria
Inclusion Criteria:
1. Age greater than or equal to 18 years
2. Concordance of the patient through the end of a written consent form approved by the
local Ethics Committee;
3. 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.
4. Iliac axes: the distal neck length greater than 10mm; the intima to intima diameter
between 7 and 20mm.
5. Present at least one of the following:
- Aneurysm diameter > 4.5 cm,
- Aneurysm that has increased in size from 0.5cm in the last six months,
- aneurysm with maximum diameter greater at least one and half times the expected
normal aortic diameter.
6. Patient who has access to the iliac or femoral artery for stent implantation in the
abdominal aorta.
7. The patient is able to meet the follow-up examination in 30 days, 180 days and 360
days.
Exclusion Criteria:
1. Pregnant or lactating women.
2. Patients with dissecting aneurysm.
3. Patients with acute symptoms of ruptured aneurysm.
4. Patient with acute vascular injury.
5. Patients referred for emergency treatment.
6. Patients with tortuous iliac / femoral exceedingly difficult to access.
7. Patient with abdominal aortic dissection.
8. Patient with congenital anomalies after the placement of the stent will cause the main
blood flow occlusion.
9. The patient with unstable angina.
10. Morbid obesity, or other clinical conditions that severely inhibit visualization of
the USG of the aorta.
11. Patient with a history of connective tissue disease syndrome (eg, Marfan or
Ehler's-Danlos syndrome).
12. Patient with a history of bleeding with the refusal of blood transfusions.
13. Patients with known hypersensitivity to the means of anticoagulation or contrast.
14. Patient with chronic renal failure (creatinine increase greater than or equal to 2.0
mg / dL).
15. Mycotic aneurysm or a systemic infection activates
16. Patient with a known allergy or intolerance to the components of these devices.
17. Patient is currently participating in another clinical trial investigating whether the
device or drug.
18. Patient with other medical observations, social or psychological, according to the
investigator's opinion, impossible to receive this treatment, the procedures and
continuation of the pre and post-treatment.
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Álvaro Razuk, Medicine, ,
Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT01368679
Organization ID
Scitech 003
Responsible Party
Sponsor
Study Sponsor
Scitech Produtos Medicos Ltda
Study Sponsor
Álvaro Razuk, Medicine, Principal Investigator, Irmandade da Santa Casa de Misericórdia de São Paulo
Verification Date
November 2014