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

This study is not yet open for participant recruitment.
Verified August 2012 by Scitech Produtos Medicos Ltda
Sponsor:
Information provided by:
Scitech Produtos Medicos Ltda
ClinicalTrials.gov Identifier:
NCT01368679
First received: June 6, 2011
Last updated: August 9, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Cardiovascular Diseases
Abdominal Aortic Aneurysm
Procedure: Endoprothesis Implantation
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Scitech Produtos Medicos Ltda:

Primary Outcome Measures:
  • Evaluation of Adverse Events [ Time Frame: Adverse Events ] [ Designated as safety issue: Yes ]
    • 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.


Secondary Outcome Measures:
  • Evaluation the performance of the stent delivery system [ Time Frame: Performance of stent-grift ] [ Designated as safety issue: Yes ]

    Evaluate the performance of the stent delivery system:

    1. Successful delivery of the stent in the abdominal aorta and exclusion or treatment of abdominal aortic aneurysm.
    2. follow endoleaks type I, III and IV after 30, 180, and 360 days.
    3. Incidence of major adverse events at 180 and 360 days after implantation or at any time.


Estimated Enrollment: 20
Study Start Date: June 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Names:
  • stenting
  • endovascular procedure

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368679

Contacts
Contact: Telmo César, Nursing 55 11 2176-7000 telmomcesar@yahoo.com.br

Locations
Brazil
Hospital de Caridade Not yet recruiting
São Francisco do Sul, Santa Catarina, Brazil, 89240-000
Contact: Elisa Kretzer Santos, Administrator       elisa_ks@hotmail.com   
Principal Investigator: Cristiano Torres Bortoluzzi, Medicine         
Irmandade da Santa Casa de Misericórdia de São Paulo Not yet recruiting
São Paulo, Brazil, 01221-020
Contact: Telmo Mathias Cesar, Nursing       telmomcesar@yahoo.com.br   
Principal Investigator: Álvaro Razuk Filho, Medicine         
Sponsors and Collaborators
Scitech Produtos Medicos Ltda
Investigators
Principal Investigator: Álvaro Razuk, Medicine Irmandade da Santa Casa de Misericórdia de São Paulo
  More Information

Additional Information:
No publications provided

Responsible Party: Álvaro Razuk Filho, MD, Irmandade da Santa Casa de Misericórdia de São Paulo
ClinicalTrials.gov Identifier: NCT01368679     History of Changes
Other Study ID Numbers: Scitech 003
Study First Received: June 6, 2011
Last Updated: August 9, 2012
Health Authority: United States: Food and Drug Administration
Brazil: National Health Surveillance Agency

Keywords provided by Scitech Produtos Medicos Ltda:
Aortic Aneurysm, Abdominal
Abdominal Aortic

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Cardiovascular Diseases
Aortic Aneurysm, Abdominal
Vascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on April 16, 2014