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ORSIRO Stents Versus Xience PRIME Stents Assessed by Optical Coherence Tomography (ORSIRO_OCT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01594736
First Posted: May 9, 2012
Last Update Posted: August 4, 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.
Collaborator:
Technische Universität München
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
May 7, 2012
May 9, 2012
August 4, 2017
April 2012
June 2013   (Final data collection date for primary outcome measure)
Degree of stent strut coverage at 6 months follow-up assessed by OCT for each visible strut segment [ Time Frame: 6-18 months ]
Same as current
Complete list of historical versions of study NCT01594736 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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ORSIRO Stents Versus Xience PRIME Stents Assessed by Optical Coherence Tomography
Intracoronary Stenting and Angiographic Results: ORSIRO Stents Versus Xience PRIME Stents Assessed by Optical Coherence Tomography
This prospective, randomized trial will compare the extent of covered stent strut segments by assessed by Optical Coherence Tomography (OCT) of the ORSIRO DES with that of the XIENCE PRIME DES, which is the standard of choice of contemporary drug eluting stents (DES).
The ORSIRO drug eluting stent exhibits a favourable vascular healing profile from baseline to 6 months assessed by optical coherence tomography (OCT). Patients with symptomatic coronary artery disease without cardiogenic shock who will undergo coronary angiography and willing to participate in the trial will receive before the procedure a loading dose of P2Y12 antagonists (clopidogrel, prasugrel or ticagrelor). Eligible patients who do not meet the exclusion criteria and for whom PCI will be considered as the appropriate form of revascularization will be randomly assigned to the ORSIRO or the XIENCE PRIME DES in the relation 1 x ORSIRO: 1 x XIENCE PRIME. All patients will receive periprocedural intravenous aspirin and heparin or bivalirudin. After the intervention patients will receive aspirin indefinitely and P2Y12 antagonists for at least 6 months. The intravascular imaging by OCT will be performed at the 6-8 months follow-up angiography.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Coronary Heart Disease
  • Drug: ORSIRO
    due randomization ORSIRO will be implanted
  • Device: XIENCE PRIME DES
    due randomization XIENCE PRIME DES will be implanted
  • Active Comparator: ORSIRO
    Intervention: Drug: ORSIRO
  • Active Comparator: XIENCE PRIME DES
    Intervention: Device: XIENCE PRIME DES
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2013
June 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% stenosis located in native coronary vessels.
  • Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
  • In women with childbearing potential a negative pregnancy test is mandatory.
  • AHA type A, B1 and B2 lesions.

Exclusion Criteria:

  • Lesion length > 25 mm requiring a stent length > 28 mm
  • Target lesion located in the left main trunk.
  • In-stent restenosis.
  • Acute myocardial infarction
  • Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 18 months or that may result in protocol non-compliance.
  • Known allergy to the study medications: sirolimus, everolimus
  • Inability to take dual antiplatelet therapy for at least 6 months.
  • The presence of bifurcation lesions
  • The presence of calcified lesions
  • Pregnancy (present, suspected or planned) or positive pregnancy test.
  • Previous enrollment in this trial.
  • Patient's inability to fully cooperate with the study protocol
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01594736
MJ-MRI-ORSIRO_OCT-V3.1
No
Not Provided
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Deutsches Herzzentrum Muenchen
Deutsches Herzzentrum Muenchen
Technische Universität München
Principal Investigator: Michael Joner, MD Deutsches Herzzentrum München
Deutsches Herzzentrum Muenchen
August 2017

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