DESTINY TRIAL (Inspiron x Biomatrix)

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Inspiron Stent; Device: Biomatrix Flex Stent

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 Type: Interventional
• Enrollment (Actual): 170
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Hospital Santa Marcelina
  • Bahia
    • Salvador, Bahia, Brazil
      • Hospital Santa Izabel
  • Goiás
    • Goiânia, Goiás, Brazil
      • Encore - Cardiologia e Radiologia Intervencionista
  • PR
    • Curitiba, PR, Brazil
      • Hospital Cardiológico Costantini
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Instituto de Cardiologia do Rio Grande do Sul
  • SP
    • São Paulo, SP, Brazil
      • Instituto Dante Pazzanese de Cardiologia
    • São Paulo, SP, Brazil
      • Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
    • São Paulo, SP, Brazil
      • Hospital Bandeirantes de São Paulo
    • São Paulo, SP, Brazil
      • Instituto de Assistência Médica ao Servidor Público Estadual
    • São Paulo, SP, Brazil
      • Santa Casa de Misericordia de Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inspiron Stent; Stent Inspiron with Sirolimus	Device: Inspiron Stent; stent implantation; Other Names: Angioplasty
Active Comparator: Biomatrix Flex Stent; Stent Biomatrix Flex with biolimus	Device: Biomatrix Flex Stent; stent implantation; Other Names: Angioplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Scitech Produtos Medicos Ltda
• Investigators: Principal Investigator: Pedro Lemos, Instituto do Coração - InCor

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): March 21, 2019

Study Registration Dates

• First Submitted: December 27, 2012
• First Submitted That Met QC Criteria: May 16, 2013
• First Posted (Estimate): May 17, 2013

Study Record Updates

• Last Update Posted (Actual): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 21, 2019
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Drug eluting stent; thrombosis; Coronary artery
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: Scitech 004