ORSIRO Stents Versus Xience PRIME Stents Assessed by Optical Coherence Tomography
ORSIRO_OCT
Intracoronary Stenting and Angiographic Results: ORSIRO Stents Versus Xience PRIME Stents Assessed by Optical Coherence Tomography
1 other identifier
interventional
30
1 country
2
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 7, 2012
CompletedFirst Posted
Study publicly available on registry
May 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedAugust 4, 2017
August 1, 2017
1.2 years
May 7, 2012
August 3, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Degree of stent strut coverage at 6 months follow-up assessed by OCT for each visible strut segment
6-18 months
Study Arms (2)
ORSIRO
ACTIVE COMPARATORXIENCE PRIME DES
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Deutsches Herzzentrum Muenchenlead
- Technical University of Munichcollaborator
Study Sites (2)
Deutsches Herzzentrum München
Munich, Bavaria, 80636, Germany
Klinikum rechts der Isar
Munich, Bavaria, 81675, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Joner, MD
Deutsches Herzzentrum München
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2012
First Posted
May 9, 2012
Study Start
April 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
August 4, 2017
Record last verified: 2017-08