Intracoronary Stenting and Angiographic Results: ORSIRO Stents Versus Xience PRIME Stents Assessed by Optical Coherence Tomography (ORSIRO OCT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Deutsches Herzzentrum Muenchen
Sponsor:
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT01594736
First received: May 7, 2012
Last updated: July 1, 2013
Last verified: July 2013

May 7, 2012
July 1, 2013
April 2012
September 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01594736 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Intracoronary Stenting and Angiographic Results: 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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Recruiting
30
January 2015
September 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
Both
18 Years and older
No
Germany
 
NCT01594736
MJ-MRI-ORSIRO_OCT-V3.1
No
Deutsches Herzzentrum Muenchen
Deutsches Herzzentrum Muenchen
Not Provided
Not Provided
Deutsches Herzzentrum Muenchen
July 2013

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