DESTINY TRIAL (Inspiron x Biomatrix)

NCT ID: NCT01856088

Last Updated: 2019-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2019-03-21

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Inspiron Stent

Stent Inspiron with Sirolimus

Group Type: EXPERIMENTAL

Inspiron Stent

Intervention Type: DEVICE

stent implantation

Biomatrix Flex Stent

Stent Biomatrix Flex with biolimus

Group Type: ACTIVE_COMPARATOR

Biomatrix Flex Stent

Intervention Type: DEVICE

stent implantation

Interventions

Inspiron Stent

stent implantation

Intervention Type: DEVICE

Biomatrix Flex Stent

stent implantation

Intervention Type: DEVICE

Other Intervention Names

Angioplasty; Angioplasty

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scitech Produtos Medicos Ltda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pedro Lemos

Role: PRINCIPAL_INVESTIGATOR

Instituto do Coração - Incor

Locations

Hospital Santa Izabel

Salvador, Estado de Bahia, Brazil

Encore - Cardiologia e Radiologia Intervencionista

Goiânia, Goiás, Brazil

Hospital Cardiologico Costantini

Curitiba, Paraná, Brazil

Instituto de Cardiologia do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Bandeirantes de São Paulo

São Paulo, São Paulo, Brazil

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, Brazil

Instituto de Assistência Médica ao Servidor Publico Estadual

São Paulo, São Paulo, Brazil

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, São Paulo, Brazil

Santa Casa de Misericórdia de São Paulo

São Paulo, São Paulo, Brazil

Hospital Santa Marcelina

São Paulo, , Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 26352896 (View on PubMed)

Related Links

http://www.scitechmed.com

Sponsor site

http://portal2.saude.gov.br/sisnep

National Information System on Ethics in Research Involving Human

Other Identifiers

Scitech 004

Identifier Type: -

Identifier Source: org_study_id