DESTINY TRIAL (Inspiron x Biomatrix)

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Inspiron Stent; Device: Biomatrix Flex Stent

• Registration Number: NCT01856088
• Lead Sponsor: Scitech Produtos Medicos Ltda

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.

Study Timeline

• Study First Submitted: 2012-12-27
• Study Start: 2013-05
• Study First Submitted QC: 2013-05-16
• Study First Posted: 2013-05-17
• Primary Completion: 2014-09
• Status Verified: 2018-04
• Study Completion: 2019-03-21
• Last Update Submitted: 2019-03-21
• Last Update Posted: 2019-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inspiron Stent	Inspiron Stent	Stent Inspiron with Sirolimus
Biomatrix Flex Stent	Biomatrix Flex Stent	Stent Biomatrix Flex with biolimus

Primary Outcome Measures

Name	Time	Method
Lumen Loss	9 months after the procedure	For an accurate assessment of the stent conditions 9 months after implantation, a follow-up catheterization will be performed at the 9 months visit in order to measure the diameter of the artery at the stented site.; 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.

Secondary Outcome Measures

Name	Time	Method
Adverse Cardiac Events	30 days, 4, 9, 12 months and 2, 3, 4, 5 years after the procedure.	The clinical follow-up should be performed during the index procedure at 30 days, 4, 9, 12 months and 2, 3, 4, 5 years after the procedure, and should consist of an assessment of the angina status (according to the Canadian Cardiovascular Society Classification and the Braunwald for unstable angina) and major adverse cardiac avents and any interventional treatment (e.g: repeated targetlesion revascularization or recurrent ischemia)

Trial Locations

Locations (10)

Hospital Santa Izabel; 🇧🇷 Salvador, Bahia, Brazil

Encore - Cardiologia e Radiologia Intervencionista; 🇧🇷 Goiânia, Goiás, Brazil

Hospital Cardiologico Costantini; 🇧🇷 Curitiba, PR, Brazil

Instituto de Cardiologia do Rio Grande do Sul; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Hospital Bandeirantes de São Paulo; 🇧🇷 São Paulo, SP, Brazil

Instituto Dante Pazzanese de Cardiologia; 🇧🇷 São Paulo, SP, Brazil

Instituto de Assistência Médica ao Servidor Publico Estadual; 🇧🇷 São Paulo, SP, Brazil

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP; 🇧🇷 São Paulo, SP, Brazil

Santa Casa de Misericórdia de São Paulo; 🇧🇷 São Paulo, SP, Brazil

Hospital Santa Marcelina; 🇧🇷 São Paulo, Brazil