We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

DESTINY TRIAL (Inspiron x Biomatrix)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01856088
First Posted: May 17, 2013
Last Update Posted: April 25, 2017
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.
Information provided by (Responsible Party):
Scitech Produtos Medicos Ltda
  Purpose
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.

Condition Intervention Phase
Coronary Artery Disease Device: Inspiron Stent Device: Biomatrix Flex Stent Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Scitech Produtos Medicos Ltda:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 170
Study Start Date: May 2013
Estimated Study Completion Date: January 2018
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inspiron Stent
Stent Inspiron with Sirolimus
Device: Inspiron Stent
stent implantation
Other Name: Angioplasty
Active Comparator: Biomatrix Flex Stent
Stent Biomatrix Flex with biolimus
Device: Biomatrix Flex Stent
stent implantation
Other Name: Angioplasty

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01856088


Locations
Brazil
Hospital Santa Izabel
Salvador, Bahia, Brazil
Encore - Cardiologia e Radiologia Intervencionista
Goiânia, Goiás, Brazil
Hospital Cardiologico Costantini
Curitiba, PR, Brazil
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Bandeirantes de São Paulo
São Paulo, SP, 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, Brazil
Hospital Santa Marcelina
São Paulo, Brazil
Sponsors and Collaborators
Scitech Produtos Medicos Ltda
Investigators
Principal Investigator: Pedro Lemos Instituto do Coração - Incor
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Scitech Produtos Medicos Ltda
ClinicalTrials.gov Identifier: NCT01856088     History of Changes
Other Study ID Numbers: Scitech 004
First Submitted: December 27, 2012
First Posted: May 17, 2013
Last Update Posted: April 25, 2017
Last Verified: April 2017

Keywords provided by Scitech Produtos Medicos Ltda:
Coronary artery
Drug eluting stent
thrombosis

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases