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

NCT01368679 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2014-11-19

No results posted yet for this study

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

Interventions

PROCEDURE

Endoprothesis Implantation

stent implantation in the abdominal artery using endovascular

Sponsors & Collaborators

  • Scitech Produtos Medicos Ltda

    lead INDUSTRY

Principal Investigators

  • Álvaro Razuk, Medicine · Irmandade da Santa Casa de Misericórdia de São Paulo

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01368679 on ClinicalTrials.gov