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

This study has been completed.
Sponsor:
Collaborator:
Technische Universität München
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT01594736
First received: May 7, 2012
Last updated: August 3, 2017
Last verified: August 2017
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Enrollment: 30
Study Start Date: April 2012
Study Completion Date: June 2013
Primary Completion Date: June 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

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier: NCT01594736

Locations
Germany
Deutsches Herzzentrum München
Munich, Bavaria, Germany, 80636
Klinikum rechts der Isar
Munich, Bavaria, Germany, 81675
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Technische Universität München
Investigators
Principal Investigator: Michael Joner, MD Deutsches Herzzentrum München
  More Information

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: August 3, 2017

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

ClinicalTrials.gov processed this record on September 21, 2017