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

This study is currently recruiting participants.
Verified May 2012 by Deutsches Herzzentrum Muenchen
Sponsor:
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT01594736
First received: May 7, 2012
Last updated: May 8, 2012
Last verified: May 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: April 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ORSIRO Drug: ORSIRO
due randomization ORSIRO will be implanted
Active Comparator: XIENCE PRIME DES Device: XIENCE PRIME DES
due randomization XIENCE PRIME DES will be implanted

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594736

Locations
Germany
Deutsches Herzzentrum München Recruiting
Munich, Bavaria, Germany, 80636
Contact: Michael Joner, MD         joner@dhm.mhn.de    
Principal Investigator: Michael Joner, MD            
Klinikum rechts der Isar Recruiting
Munich, Bavaria, Germany, 81675
Contact: Karl-Ludwig Laugwitz, MD         laugwitz@med1-tum.de    
Principal Investigator: Karl-Ludwig Laugwitz, MD            
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
  More Information

No publications provided

Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT01594736     History of Changes
Other Study ID Numbers: MJ-MRI-ORSIRO_OCT-V3.1
Study First Received: May 7, 2012
Last Updated: May 8, 2012
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on May 21, 2013