Clinical trial NCT01368679: 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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Cardiovascular Diseases
Abdominal Aortic Aneurysm
Keywords: Aortic Aneurysm, Abdominal
Abdominal Aortic
Lead sponsor: Scitech Produtos Medicos Ltda
Sponsor class: INDUSTRY
First posted: 2011-06-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Evaluation of Adverse Events
timeFrame: Adverse Events
Secondary outcomes:
measure: Evaluation the performance of the stent delivery system
timeFrame: Performance of stent-grift
Other outcomes:
Locations:
city: São Francisco do Sul
country: Brazil
facility: Hospital de Caridade
state: Santa Catarina
city: São Paulo
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de São Paulo
Study officials:
affiliation: Irmandade da Santa Casa de Misericórdia de São Paulo
name: Álvaro Razuk, Medicine
role: PRINCIPAL_INVESTIGATOR
References: