This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2013 by Deutsches Herzzentrum Muenchen.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen Identifier:
First received: May 7, 2012
Last updated: July 1, 2013
Last verified: July 2013
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).

Condition Intervention Phase
Coronary Heart Disease Drug: ORSIRO Device: XIENCE PRIME DES Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intracoronary Stenting and Angiographic Results: ORSIRO Stents Versus Xience PRIME Stents Assessed by Optical Coherence Tomography

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Degree of stent strut coverage at 6 months follow-up assessed by OCT for each visible strut segment [ Time Frame: 6-18 months ]

Estimated Enrollment: 30
Study Start Date: April 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ORSIRO Drug: ORSIRO
due randomization ORSIRO will be implanted
due randomization XIENCE PRIME DES will be implanted


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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01594736

Deutsches Herzzentrum München Recruiting
Munich, Bavaria, Germany, 80636
Contact: Michael Joner, MD   
Principal Investigator: Michael Joner, MD         
Klinikum rechts der Isar Recruiting
Munich, Bavaria, Germany, 81675
Contact: Karl-Ludwig Laugwitz, MD   
Principal Investigator: Karl-Ludwig Laugwitz, MD         
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
  More Information

Responsible Party: Deutsches Herzzentrum Muenchen Identifier: NCT01594736     History of Changes
Other Study ID Numbers: MJ-MRI-ORSIRO_OCT-V3.1
Study First Received: May 7, 2012
Last Updated: July 1, 2013

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases processed this record on July 21, 2017