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

November 18, 2014 updated by: Scitech Produtos Medicos Ltda

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)

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.

Study Overview

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 Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • São Paulo, Brazil, 01221-020
        • Irmandade Da Santa Casa De Misericordia De Sao Paulo
    • Santa Catarina
      • São Francisco do Sul, Santa Catarina, Brazil, 89240-000
        • Hospital de Caridade

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

stent implantation in the abdominal artery using endovascular
Other Names:
  • stenting
  • endovascular procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Adverse Events

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation the performance of the stent delivery system
Time Frame: Performance of stent-grift

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.
Performance of stent-grift

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Álvaro Razuk, Medicine, Irmandade Da Santa Casa De Misericordia De Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 7, 2022

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

June 6, 2011

First Submitted That Met QC Criteria

June 7, 2011

First Posted (Estimate)

June 8, 2011

Study Record Updates

Last Update Posted (Estimate)

November 19, 2014

Last Update Submitted That Met QC Criteria

November 18, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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