Clinical trial NCT01856088: DESTINY TRIAL (Inspiron x Biomatrix)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Coronary artery
Drug eluting stent
thrombosis
Lead sponsor: Scitech Produtos Medicos Ltda
Sponsor class: INDUSTRY
First posted: 2013-05-17
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 arteries.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lumen Loss
timeFrame: 9 months after the procedure
Secondary outcomes:
measure: Adverse Cardiac Events
timeFrame: 30 days, 4, 9, 12 months and 2, 3, 4, 5 years after the procedure.
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Hospital Santa Izabel
state: Bahia
city: Goiânia
country: Brazil
facility: Encore - Cardiologia e Radiologia Intervencionista
state: Goiás
city: Curitiba
country: Brazil
facility: Hospital Cardiologico Costantini
state: PR
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia do Rio Grande do Sul
state: Rio Grande Do Sul
city: São Paulo
country: Brazil
facility: Hospital Bandeirantes de São Paulo
state: SP
city: São Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
state: SP
city: São Paulo
country: Brazil
facility: Instituto de Assistência Médica ao Servidor Publico Estadual
state: SP
city: São Paulo
country: Brazil
facility: Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
state: SP
city: São Paulo
country: Brazil
facility: Santa Casa de Misericórdia de São Paulo
state: SP
city: São Paulo
country: Brazil
facility: Hospital Santa Marcelina
Study officials:
affiliation: Instituto do Coração - Incor
name: Pedro Lemos
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lemos PA, Abizaid AA, Meireles GC, Sarmento-Leite R, Prudente M, Cantarelli M, Dourado AD, Mariani J Jr, Perin MA, Costantini C, Costa RA, Costa JR, Chamie D, Campos CA, Ribeiro E. Metallic Limus-Eluting Stents Abluminally Coated with Biodegradable Polymers: Angiographic and Clinical Comparison of a Novel Ultra-Thin Sirolimus Stent Versus Biolimus Stent in the DESTINY Randomized Trial. Cardiovasc Ther. 2015 Dec;33(6):367-71. doi: 10.1111/1755-5922.12159.