This trial is active, not recruiting.

Condition coronary artery disease
Treatments inspiron stent, biomatrix flex stent
Phase phase 4
Sponsor Scitech Produtos Medicos Ltda
Start date May 2013
End date September 2014
Trial size 170 participants
Trial identifier NCT01856088, Scitech 004


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 arteries.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Stent Inspiron with Sirolimus
inspiron stent Angioplasty
stent implantation
(Active Comparator)
Stent Biomatrix Flex with biolimus
biomatrix flex stent Angioplasty
stent implantation

Primary Outcomes

Lumen Loss
time frame: 9 months after the procedure

Secondary Outcomes

Adverse Cardiac Events
time frame: 30 days, 4, 9, 12 months and 2, 3, 4, 5 years after the procedure.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Age > 18 years; 2. Symptomatic ischemic heart disease and / or objective evidence of myocardial ischemia with one or two target lesions located in different epicardial vessels; 3. A(s) lesion(s) to target(m) must be: 1. Again (not restenotic); 2. Located in a native coronary artery diameter from 2.5 to 3.5 mm (visual); 3. Can be treated with a single stent up to 29 mm in length; 4. Obstruction with stenosis > 50% diameter (visual); 4. Acceptable candidate for CABG; 5. 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 Criteria: 1. Women of childbearing age with no history of surgical sterilization; 2. Myocardial infarction with Q wave occurred in the last 48 hours before the index procedure; 3. Myocardial infarction with or without Q wave with cardiac markers even at high levels; 4. Ejection fraction < 30%; 5. Impaired renal function (creatinine> 2.0 mg / dl) or calculated creatinine clearance < 60 ml / min; 6. Platelet count <100,000 cells/mm3 or > 700,000 cells/mm3; 7. Total leukocyte count <3000 cells/mm3; 8. Documented or suspected liver disease (including laboratory evidence of hepatitis); 9. Heart transplant recipient; 10. Known allergies to aspirin, clopidogrel, ticlopidine, paclitaxel, sirolimus, heparin or stainless steel; 11. Patient with a life expectancy less than 12 months; 12. Any significant medical condition which in the opinion of the investigator would interfere with the ideal of patient participation in this study; 13. Participation in other research in the last 12 months, unless there is direct benefit to the research subject; 14. Coronary angioplasty (with or without stenting) for less than 6 months anywhere in the target vessel; 15. Coronary angioplasty (with or without stenting) prior to any time in that segment Diste less than 5 mm (proximal or distal) of the lesion; 16. 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 1. Restenotic target lesion; 2. Need for treatment for more than one lesion in the same vessel; 3. Need for treatment with three or more lesions in the same procedure; 4. Target vessel diameter <2.5 mm or> 3.5 mm (visual); 5. Target lesion long not susceptible to treatment with a single stent to 29mm in length, according to the judgment of the operator; 6. Lesion of the coronary artery unprotected ( > 50% stenosis); 7. Angiographic thrombus; 8. Target lesion in surgical graft; 9. Total occlusion (TIMI anterograde flow 0 or 1); 10. Ostial lesion; 11. The target lesion bifurcation with side branch that may require intervention during the procedure, with or without stenting; 12. Injuries that are impossible to anticipate predilatation successfully or that is necessary to use rotablator; 13. The target vessel with excessive tortuosity.

Additional Information

Official title Stents Coated With the Biodegradable Polymer on Their Abluminal Faces and Elution of Sirolimus Versus Biolimus Elution for the Treatment of de Novo Coronary Lesions - Destiny Trial
Principal investigator Pedro Lemos
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 randomized patients. Patients will be followed for 60 months after the procedure. All new patients will be undergoing angiography for evaluation at 9 months. A subgroup of 60 patients will be evaluated with volumetric intravascular ultrasound at 9 months. Also, a subgroup of 21 patients will be evaluated with optical coherence tomography at the end of the index procedure and 9 months. It is anticipated that the total study duration is 72 months: 12 months to complete the admission of patients and 60 months of follow-up.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Scitech Produtos Medicos Ltda.