DESTINY TRIAL (Inspiron x Biomatrix)

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01856088
• Other study ID #: Scitech 004
• Status: Completed
• Phase: Phase 4
• Start date: May 2013
• Est. completion date: March 21, 2019

Study information

• Verified date: April 2018
• Source: Scitech Produtos Medicos Ltda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: March 21, 2019
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Inspiron Stent
stent implantation
• Biomatrix Flex Stent
stent implantation

Locations

Country	Name	City	State
Brazil	Hospital Cardiologico Costantini	Curitiba	PR
Brazil	Encore - Cardiologia e Radiologia Intervencionista	Goiânia	Goiás
Brazil	Instituto de Cardiologia do Rio Grande do Sul	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital Santa Izabel	Salvador	Bahia
Brazil	Hospital Bandeirantes de São Paulo	São Paulo	SP
Brazil	Hospital Santa Marcelina	São Paulo
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

Sponsors (1)

Lead Sponsor	Collaborator
Scitech Produtos Medicos Ltda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lumen Loss	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.	9 months after the procedure
Secondary	Adverse Cardiac Events	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)	30 days, 4, 9, 12 months and 2, 3, 4, 5 years after the procedure.

External Links

•   National Information System on Ethics in Research Involving Human
•   Sponsor site