DESTINY TRIAL (Inspiron x Biomatrix)

Scitech Produtos Medicos

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Device: Inspiron Stent; Device: Biomatrix Flex Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT01856088

Scitech 004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Inspiron Stent

Experimental group

Description:

Stent Inspiron with Sirolimus

Treatment:

Device: Inspiron Stent

Biomatrix Flex Stent

Active Comparator group

Description:

Stent Biomatrix Flex with biolimus

Treatment:

Device: Biomatrix Flex Stent