A Clinical Study to Evaluate the Safety and Performance of the Modular AAA Stent-Graft System

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 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

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