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

NCT01368679 | Withdrawn Phase 3 DMC

• 1 other identifier: Scitech 003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiovascular Diseases; Abdominal Aortic Aneurysm

Keywords

Aortic Aneurysm, Abdominal; Abdominal Aortic

Outcome Measures

Primary Outcomes (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.

  Adverse Events

Secondary Outcomes (1)

• Evaluation the performance of the stent delivery system

  Performance of stent-grift

Study Arms (1)

Endoprothesis Scitech

EXPERIMENTAL

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

Interventions

Endoprothesis Implantation PROCEDURE

stent implantation in the abdominal artery using endovascular

Also known as: stenting, endovascular procedure

Endoprothesis Scitech

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Scitech Produtos Medicos Ltda: lead

Study Sites (2)

Hospital de Caridade

São Francisco do Sul, Santa Catarina, 89240-000, Brazil

Location

Irmandade da Santa Casa de Misericórdia de São Paulo

São Paulo, São Paulo, 01221-020, Brazil

Location

Related Links

• Site sponsor
• Site about the location that will be done the study. Location where the principal investigator works.
• National Information System on Ethics in Research involving Human

MeSH Terms

Conditions

Cardiovascular Diseases; Aortic Aneurysm, Abdominal

Interventions

Stents; Endovascular Procedures

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Álvaro Razuk, Medicine

  Irmandade da Santa Casa de Misericórdia de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2011
• First Posted: June 8, 2011
• Last Updated: November 19, 2014

Record last verified: 2014-11

Locations

BR (2)