DESTINY TRIAL (Inspiron x Biomatrix)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Scitech Produtos Medicos Ltda
Sponsor:
Information provided by (Responsible Party):
Scitech Produtos Medicos Ltda
ClinicalTrials.gov Identifier:
NCT01856088
First received: December 27, 2012
Last updated: June 24, 2013
Last verified: May 2013

December 27, 2012
June 24, 2013
May 2013
November 2013   (final data collection date for primary outcome measure)
Lumen Loss [ Time Frame: 9 months after the procedure ] [ Designated as safety issue: Yes ]

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 ClinicalTrials.gov Archive Site
Adverse Cardiac Events [ Time Frame: 30 days, 4, 9, 12 months and 2, 3, 4, 5 years after the procedure. ] [ Designated as safety issue: Yes ]
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 Faces and Elution of Sirolimus Abluminais Versus Elution Biolimus for the Treatment of Coronary Lesions Again - Randomized Destiny

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
Device: Inspiron ™ stent eluting sirolimus or Biomatrix™ stent eluting biolimus
Site preparation acces should be performed as per standard hospital procedures It is recommended to cross the target lesion with 0,014 inch exchange-lenght guide wire. If necessary the involved lesion should be predilated with appropriately sized balloons using standard techniques. It is strongly encouraged that the Investigators use similar materials and techniques throughout the study to maintain consistency and standardization of care. A stent consists of an endovascular prosthesis with a metalic mesh structure that is implanted at the site of the artery blockage via catheterization procedure. The objective of stenting is to obtain an angiographic appearance of the expanded stent only outside the limits of the target vessel filled with contrast medium.
Other Names:
  • Drug eluting stent
  • Angiography
  • Experimental: Drug Eluting Stent
    Stent Inspiron with Sirolimus
    Intervention: Device: Inspiron ™ stent eluting sirolimus or Biomatrix™ stent eluting biolimus
  • Active Comparator: Drug eluting stent
    Stent Biomatrix Flex with biolimus
    Intervention: Device: Inspiron ™ stent eluting sirolimus or Biomatrix™ stent eluting biolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
165
February 2018
November 2013   (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.

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.
Both
18 Years and older
No
Contact: Adriana Gouveia, nursing 55 11 98920-2999 adriana.gouveia@cmsmedical.com.br
Contact: Patricia Pereira, Medicine 55 11 2661 5368 patricia.pereira@incor.usp.br
Brazil
 
NCT01856088
Scitech 004
Yes
Scitech Produtos Medicos Ltda
Scitech Produtos Medicos Ltda
Not Provided
Principal Investigator: Pedro Lemos Instituto do Coração - Incor
Scitech Produtos Medicos Ltda
May 2013

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