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)
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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