Coronary Heart DiseasePhase 4ORSIRO_OCTNCT01594736
ORSIRO Stents Versus Xience PRIME Stents Assessed by Optical Coherence Tomography
A Phase 4 study testing ORSIRO and XIENCE PRIME DES in people with Coronary Heart Disease, run by Deutsches Herzzentrum Muenchen at 2 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- ORSIRO and XIENCE PRIME DES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2012to Jun 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Deutsches Herzzentrum München
Munich, Bavaria, 80636
Klinikum rechts der Isar
Munich, Bavaria, 81675
About this study
Official title: 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).
Read the 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.
- Conditions
- Coronary Heart Disease
- Being tested
- ORSIRO, XIENCE PRIME DES
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORSIRODrug
due randomization ORSIRO will be implanted
XIENCE PRIME DESDevice
due randomization XIENCE PRIME DES will be implanted
| Study group | Role | What they receive |
|---|---|---|
| ORSIRO | Active comparator | Not described Receives: Drug: ORSIRO |
| XIENCE PRIME DES | Active comparator | Not described Receives: Device: XIENCE PRIME DES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of stent strut coverage at 6 months follow-up assessed by OCT for each visible strut segment
Measured: 6-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Munich
- Responsible party
- Sponsor
- Investigators
- Michael Joner, MD, Principal investigator, Deutsches Herzzentrum München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594736
- Sponsor's protocol ID
- MJ-MRI-ORSIRO_OCT-V3.1
- Acronym
- ORSIRO_OCT
- Status last verified
- Aug 2017
- First submitted
- 7 May 2012
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracoronary Stenting and Angiographic Results: ORSIRO Stents Versus Xience PRIME Stents Assessed by Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT01594736
- Acronym / sponsor ID
- ORSIRO_OCT / MJ-MRI-ORSIRO_OCT-V3.1
- Conditions
- Coronary Heart Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Collaborators
- Technical University of Munich
- Study start
- Apr 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 9 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ORSIRO | Active comparator | Drug: ORSIRO |
| XIENCE PRIME DES | Active comparator | Device: XIENCE PRIME DES |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORSIROdue randomization ORSIRO will be implanted | Drug | ORSIRO |
| XIENCE PRIME DESdue randomization XIENCE PRIME DES will be implanted | Device | XIENCE PRIME DES |
Primary outcome
Degree of stent strut coverage at 6 months follow-up assessed by OCT for each visible strut segment
Time frame: 6-18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Joner, MD principal investigator
Deutsches Herzzentrum München
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ORSIRO and XIENCE PRIME DES in people with Coronary Heart Disease, run by Deutsches Herzzentrum Muenchen at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2017.