DESTINY TRIAL (Inspiron x Biomatrix)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01856088
Recruitment Status : Active, not recruiting
First Posted : May 17, 2013
Last Update Posted : April 17, 2018
Information provided by (Responsible Party):
Scitech Produtos Medicos Ltda

December 27, 2012
May 17, 2013
April 17, 2018
May 2013
September 2014   (Final data collection date for primary outcome measure)
Lumen Loss [ Time Frame: 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.

Same as current
Complete list of historical versions of study NCT01856088 on Archive Site
Adverse Cardiac Events [ Time Frame: 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)
Same as current
Not Provided
Not Provided
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.

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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Coronary Artery Disease
  • Device: Inspiron Stent
    stent implantation
    Other Name: Angioplasty
  • Device: Biomatrix Flex Stent
    stent implantation
    Other Name: Angioplasty
  • Experimental: Inspiron Stent
    Stent Inspiron with Sirolimus
    Intervention: Device: Inspiron Stent
  • Active Comparator: Biomatrix Flex Stent
    Stent Biomatrix Flex with biolimus
    Intervention: Device: Biomatrix Flex Stent
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
January 2019
September 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Scitech 004
Not Provided
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Scitech Produtos Medicos Ltda
Scitech Produtos Medicos Ltda
Not Provided
Principal Investigator: Pedro Lemos Instituto do Coração - Incor
Scitech Produtos Medicos Ltda
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP