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Cardiovascular DiseasesPhase 3Stent-GraftNCT01368679

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

A Phase 3 study testing Endoprothesis Implantation in people with Cardiovascular Diseases and Abdominal Aortic Aneurysm, run by Scitech Produtos Medicos SA at 2 sites in Brazil.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Endoprothesis Implantation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesBrazil
Study dates
Start not givento not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Aneurysm diameter > 4.5 cm,
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  • 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.
  • 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.

Who cannot join

  • Pregnant or lactating women.
  • Patients with dissecting aneurysm.
  • Patients with acute symptoms of ruptured aneurysm.
  • Patient with acute vascular injury.
  • Patients referred for emergency treatment.
  • Patients with tortuous iliac / femoral exceedingly difficult to access.
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  • Patient with abdominal aortic dissection.
  • Patient with congenital anomalies after the placement of the stent will cause the main blood flow occlusion.
  • The patient with unstable angina.
  • Morbid obesity, or other clinical conditions that severely inhibit visualization of the USG of the aorta.
  • Patient with a history of connective tissue disease syndrome (eg, Marfan or Ehler's-Danlos syndrome).
  • Patient with a history of bleeding with the refusal of blood transfusions.
  • Patients with known hypersensitivity to the means of anticoagulation or contrast.
  • Patient with chronic renal failure (creatinine increase greater than or equal to 2.0 mg / dL).
  • Mycotic aneurysm or a systemic infection activates
  • Patient with a known allergy or intolerance to the components of these devices.
  • Patient is currently participating in another clinical trial investigating whether the device or drug.
  • 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.

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

  • Hospital de Caridade

    São Francisco do Sul, Santa Catarina, 89240-000

  • Irmandade da Santa Casa de Misericórdia de São Paulo

    São Paulo, São Paulo, 01221-020

Other trials in Brazil

About this study

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)

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.

Read the 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.

Being tested
Endoprothesis Implantation
Keywords
Aortic Aneurysm, Abdominal, Abdominal Aortic
Medical subject headings
Cardiovascular Diseases, Aortic Aneurysm, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoprothesis ImplantationProcedure or surgery

    Also called stenting, endovascular procedure

    stent implantation in the abdominal artery using endovascular

Study groups in NCT01368679
Study groupRoleWhat they receive
Endoprothesis ScitechExperimentalThe 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
Receives: Procedure: Endoprothesis Implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of 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.

    Measured: Adverse Events

Secondary outcomes (1)

  1. Evaluation the performance of the stent delivery system

    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.

    Measured: Performance of stent-grift

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01368679
Sponsor's protocol ID
Scitech 003
Acronym
Stent-Graft
Status last verified
Nov 2014
First submitted
6 Jun 2011
Last updated
19 Nov 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Endoprothesis Implantation in people with Cardiovascular Diseases and Abdominal Aortic Aneurysm, run by Scitech Produtos Medicos SA at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 19 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of Adverse Events (time frame: Adverse Events). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01368679.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2014.

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