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Status:

COMPLETED

DESTINY TRIAL (Inspiron x Biomatrix)

Lead Sponsor:

Scitech Produtos Medicos Ltda

Conditions:

Coronary Artery Disease

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

The main objective of this study is to evaluate the effectiveness of stent Inspiron ™ sirolimus-eluting and coating the abluminal biodegradable stent Biomatrix Flex ™ lesions in native coronary arteri...

Detailed Description

This is a study of non-inferiority, multicentre, prospective, randomized into two treatment arms: I) Inspiron ™ stent eluting sirolimus or II) ™ Biomatrix stent eluting biolimus. Are a total of 165 ra...

Eligibility Criteria

Inclusion

  • Age \> 18 years;
  • Symptomatic ischemic heart disease and / or objective evidence of myocardial ischemia with one or two target lesions located in different epicardial vessels;
  • A(s) lesion(s) to target(m) must be:
  • Again (not restenotic);
  • Located in a native coronary artery diameter from 2.5 to 3.5 mm (visual);
  • Can be treated with a single stent up to 29 mm in length;
  • Obstruction with stenosis \> 50% diameter (visual);
  • Acceptable candidate for CABG;
  • The patient will be informed of the nature of the study, agree with their rules and provide a written informed consent approved by the local Ethics Committee.

Exclusion

  • Women of childbearing age with no history of surgical sterilization;
  • Myocardial infarction with Q wave occurred in the last 48 hours before the index procedure;
  • Myocardial infarction with or without Q wave with cardiac markers even at high levels;
  • Ejection fraction \< 30%;
  • Impaired renal function (creatinine\> 2.0 mg / dl) or calculated creatinine clearance \< 60 ml / min;
  • Platelet count \<100,000 cells/mm3 or \> 700,000 cells/mm3;
  • Total leukocyte count \<3000 cells/mm3;
  • Documented or suspected liver disease (including laboratory evidence of hepatitis);
  • Heart transplant recipient;
  • Known allergies to aspirin, clopidogrel, ticlopidine, paclitaxel, sirolimus, heparin or stainless steel;
  • Patient with a life expectancy less than 12 months;
  • Any significant medical condition which in the opinion of the investigator would interfere with the ideal of patient participation in this study;
  • Participation in other research in the last 12 months, unless there is direct benefit to the research subject;
  • Coronary angioplasty (with or without stenting) for less than 6 months anywhere in the target vessel;
  • Coronary angioplasty (with or without stenting) prior to any time in that segment Diste less than 5 mm (proximal or distal) of the lesion;
  • Coronary angioplasty (with or without stenting) scheduled in the first 12 months after the index procedure in any segment of the target vessel.
  • EXCLUSION CRITERIA angiographic
  • Restenotic target lesion;
  • Need for treatment for more than one lesion in the same vessel;
  • Need for treatment with three or more lesions in the same procedure;
  • Target vessel diameter \<2.5 mm or\> 3.5 mm (visual);
  • Target lesion long not susceptible to treatment with a single stent to 29mm in length, according to the judgment of the operator;
  • Lesion of the coronary artery unprotected ( \> 50% stenosis);
  • Angiographic thrombus;
  • Target lesion in surgical graft;
  • Total occlusion (TIMI anterograde flow 0 or 1);
  • Ostial lesion;
  • The target lesion bifurcation with side branch that may require intervention during the procedure, with or without stenting;
  • Injuries that are impossible to anticipate predilatation successfully or that is necessary to use rotablator;
  • The target vessel with excessive tortuosity.

Key Trial Info

Start Date :

May 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 21 2019

Estimated Enrollment :

170 Patients enrolled

Trial Details

Trial ID

NCT01856088

Start Date

May 1 2013

End Date

March 21 2019

Last Update

March 25 2019

Active Locations (10)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (10 locations)

1

Hospital Santa Izabel

Salvador, Estado de Bahia, Brazil

2

Encore - Cardiologia e Radiologia Intervencionista

Goiânia, Goiás, Brazil

3

Hospital Cardiologico Costantini

Curitiba, Paraná, Brazil

4

Instituto de Cardiologia do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil