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DESTINY TRIAL (Inspiron x Biomatrix)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Inspiron Stent
Biomatrix Flex Stent
Sponsored by
Scitech Produtos Medicos Ltda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery, Drug eluting stent, thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Santa Izabel
  • Encore - Cardiologia e Radiologia Intervencionista
  • Hospital Cardiologico Costantini
  • Instituto de Cardiologia do Rio Grande do Sul
  • Hospital Bandeirantes de São Paulo
  • Instituto Dante Pazzanese de Cardiologia
  • Instituto de Assistência Médica ao Servidor Publico Estadual
  • Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
  • Santa Casa de Misericórdia de São Paulo
  • Hospital Santa Marcelina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Inspiron Stent

Biomatrix Flex Stent

Arm Description

Stent Inspiron with Sirolimus

Stent Biomatrix Flex with biolimus

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

First Posted
December 27, 2012
Last Updated
March 21, 2019
Sponsor
Scitech Produtos Medicos Ltda
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1. Study Identification

Unique Protocol Identification Number
NCT01856088
Brief Title
DESTINY TRIAL (Inspiron x Biomatrix)
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
March 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scitech Produtos Medicos Ltda

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery, Drug eluting stent, thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspiron Stent
Arm Type
Experimental
Arm Description
Stent Inspiron with Sirolimus
Arm Title
Biomatrix Flex Stent
Arm Type
Active Comparator
Arm Description
Stent Biomatrix Flex with biolimus
Intervention Type
Device
Intervention Name(s)
Inspiron Stent
Other Intervention Name(s)
Angioplasty
Intervention Description
stent implantation
Intervention Type
Device
Intervention Name(s)
Biomatrix Flex Stent
Other Intervention Name(s)
Angioplasty
Intervention Description
stent implantation
Primary Outcome Measure Information:
Title
Lumen Loss
Description
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.
Time Frame
9 months after the procedure
Secondary Outcome Measure Information:
Title
Adverse Cardiac Events
Description
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)
Time Frame
30 days, 4, 9, 12 months and 2, 3, 4, 5 years after the procedure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years; Symptomatic ischemic heart disease and / or objective evidence of myocardial ischemia with one or two target lesions located in different epicardial vessels; A(s) lesion(s) to target(m) must be: Again (not restenotic); Located in a native coronary artery diameter from 2.5 to 3.5 mm (visual); Can be treated with a single stent up to 29 mm in length; Obstruction with stenosis > 50% diameter (visual); Acceptable candidate for CABG; 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: Women of childbearing age with no history of surgical sterilization; Myocardial infarction with Q wave occurred in the last 48 hours before the index procedure; Myocardial infarction with or without Q wave with cardiac markers even at high levels; Ejection fraction < 30%; Impaired renal function (creatinine> 2.0 mg / dl) or calculated creatinine clearance < 60 ml / min; Platelet count <100,000 cells/mm3 or > 700,000 cells/mm3; Total leukocyte count <3000 cells/mm3; Documented or suspected liver disease (including laboratory evidence of hepatitis); Heart transplant recipient; Known allergies to aspirin, clopidogrel, ticlopidine, paclitaxel, sirolimus, heparin or stainless steel; Patient with a life expectancy less than 12 months; Any significant medical condition which in the opinion of the investigator would interfere with the ideal of patient participation in this study; Participation in other research in the last 12 months, unless there is direct benefit to the research subject; Coronary angioplasty (with or without stenting) for less than 6 months anywhere in the target vessel; Coronary angioplasty (with or without stenting) prior to any time in that segment Diste less than 5 mm (proximal or distal) of the lesion; 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 Restenotic target lesion; Need for treatment for more than one lesion in the same vessel; Need for treatment with three or more lesions in the same procedure; Target vessel diameter <2.5 mm or> 3.5 mm (visual); Target lesion long not susceptible to treatment with a single stent to 29mm in length, according to the judgment of the operator; Lesion of the coronary artery unprotected ( > 50% stenosis); Angiographic thrombus; Target lesion in surgical graft; Total occlusion (TIMI anterograde flow 0 or 1); Ostial lesion; The target lesion bifurcation with side branch that may require intervention during the procedure, with or without stenting; Injuries that are impossible to anticipate predilatation successfully or that is necessary to use rotablator; The target vessel with excessive tortuosity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Lemos
Organizational Affiliation
Instituto do Coração - Incor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Santa Izabel
City
Salvador
State/Province
Bahia
Country
Brazil
Facility Name
Encore - Cardiologia e Radiologia Intervencionista
City
Goiânia
State/Province
Goiás
Country
Brazil
Facility Name
Hospital Cardiologico Costantini
City
Curitiba
State/Province
PR
Country
Brazil
Facility Name
Instituto de Cardiologia do Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Hospital Bandeirantes de São Paulo
City
São Paulo
State/Province
SP
Country
Brazil
Facility Name
Instituto Dante Pazzanese de Cardiologia
City
São Paulo
State/Province
SP
Country
Brazil
Facility Name
Instituto de Assistência Médica ao Servidor Publico Estadual
City
São Paulo
State/Province
SP
Country
Brazil
Facility Name
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
City
São Paulo
State/Province
SP
Country
Brazil
Facility Name
Santa Casa de Misericórdia de São Paulo
City
São Paulo
State/Province
SP
Country
Brazil
Facility Name
Hospital Santa Marcelina
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
26352896
Citation
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.
Results Reference
derived
Links:
URL
http://www.scitechmed.com
Description
Sponsor site
URL
http://portal2.saude.gov.br/sisnep
Description
National Information System on Ethics in Research Involving Human

Learn more about this trial

DESTINY TRIAL (Inspiron x Biomatrix)

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