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

Primary Purpose

Cardiovascular Diseases, Abdominal Aortic Aneurysm

Status

Withdrawn

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Endoprothesis Implantation

About this trial

This is an interventional treatment trial for Cardiovascular Diseases focused on measuring Aortic Aneurysm, Abdominal, Abdominal Aortic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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
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.

Sites / Locations

Hospital de Caridade
Irmandade da Santa Casa de Misericórdia de São Paulo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endoprothesis Scitech

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Evaluation the performance of the stent delivery system

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

Full Information

NCT ID

NCT01368679

First Posted

June 6, 2011

Last Updated

November 18, 2014

Sponsor

Scitech Produtos Medicos Ltda

1. Study Identification

Unique Protocol Identification Number

NCT01368679

Brief Title

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

Acronym

Stent-Graft

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

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Withdrawn

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Scitech Produtos Medicos Ltda

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiovascular Diseases, Abdominal Aortic Aneurysm

Keywords

Aortic Aneurysm, Abdominal, Abdominal Aortic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Endoprothesis Scitech

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Endoprothesis Implantation

Other Intervention Name(s)

stenting, endovascular procedure

Intervention Description

stent implantation in the abdominal artery using endovascular

Primary Outcome Measure Information:

Title

Evaluation of Adverse Events

Description

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.

Time Frame

Adverse Events

Secondary Outcome Measure Information:

Title

Evaluation the performance of the stent delivery system

Description

Time Frame

Performance of stent-grift

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Álvaro Razuk, Medicine

Organizational Affiliation

Irmandade da Santa Casa de Misericórdia de São Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital de Caridade

City

São Francisco do Sul

State/Province

Santa Catarina

ZIP/Postal Code

89240-000

Country

Brazil

Facility Name

Irmandade da Santa Casa de Misericórdia de São Paulo

City

São Paulo

ZIP/Postal Code

01221-020

Country

Brazil

12. IPD Sharing Statement

Links:

URL

http://www.scitechmed.com

Description

Site sponsor

URL

http://www.santacasasp.org.br

Description

Site about the location that will be done the study. Location where the principal investigator works.

URL

http://portal2.saude.gov.br/sisnep

Description

National Information System on Ethics in Research involving Human

Learn more about this trial

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

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