Acute Coronary SyndromePhase 4TIDES-OCTNCT02280720
Vascular Healing After Deployment of Titanium-nitride-oxide-coated OPTIMAX™ Stent and PROMUS-ELEMENT™ Everolimus-Eluting Stent
A Phase 4 study testing Stenting using Optimax™ and Stenting using PROMUS Element™ Plus in people with Acute Coronary Syndrome, run by The Hospital District of Satakunta at 4 sites in Finland.
Trial summary
The purpose of this study is to compare vascular healing of the stented segment after deployment of titanium-nitride-oxide coated cobalt-chromium Optimax™-stent stent and Promus-Element™ everolimus-eluting stent in patients with acute coronary syndromes requiring percutaneous coronary intervention. 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Stenting using Optimax™ and Stenting using PROMUS Element™ Plus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesFinland
- Study dates
- Jan 2013to Jan 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 and <80 years
- STEMI or NSTEMI (assumed by investigator to be type 1 myocardial infarction, according to universal definitions of MI; EHJ 2007; 28(20):2525-38); or unstable angina (clinical symptoms of chest pain, ecg suggestive of reversible ischemia)
- Patient is willing to comply with specified follow-up evaluations
- Patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics committee or Institutional Review Board
- Single de novo or non-stented restenosis lesion
- Patients with two-vessel disease may have undergone successful treatment of the non-target vessel with approved devices up to and including the index procedure but must be prior to the index target vessel treatment
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- Target lesion (maximum 20 mm length by visual estimation) to be covered by a single stent of maximum 23mm length
- Reference vessel diameter must be >2.5mm and <4.0mm by visual estimate.
- The vessel diameter should be measured after pre-dilation procedure and after intracoronary nitroglycerin if vasospasm is suspected
- Target lesion >50% and <100% stenosed by visual estimate
Who cannot join
- Pre-existing diagnosis of diabetes irrespective of its type
- Impaired renal function (serum creatinine >177micromol/l) or on dialysis
- Platelet count < 10 e5 cells/mm3
- Patient has a history of bleeding diathesis or coagulopathy or patients in whom antiplatelet and and/or anticoagulation therapy is contraindicated
- Patient has received organ transplant or is on a waiting list for any organ transplant
- Patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/prasugrel, stainless steel alloy, or contrast agent that cannot be adequately pre-medicated
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- Patient presents with cardiogenic shock
- Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study
- Currently participating in another intestigational drug or device study
- Unprotected left main disease
- Ostial target lesions
- Chronic total occlusion
- Calcified target lesions that cannot be adequately pre-dilated
- Target lesion has excessive tortuosity unsuitable for stent delivery and deployment
- Target lesion involving bifurcation with a side branch larger than 2.0mm in diameter
- A >30% stenosis proximal or distal to the target lesion that cannot be covered with the same stent
- Diffuse distal disease
- Prior stent in the target vessel
Trial locations and contacts
4 sites in 1 country.
Finland4 sites
Kokkola Central Hospital
Kokkola
Heart Center, Kuopio University Hospital
Kuopio
Heart Center, Satakunta Central Hospital
Pori, 28500
Heart Center, Turku University Hospital
Turku
About this study
Official title: A Randomized Prospective Multicenter Trial to Compare Vascular Healing and Vasodilation at 2 Months After Deployment of TItanium-nitride-oxide-coated OPTIMAX™ Stent and PROMUS-ELEMENT™ Drug-Eluting Stent in Patients With Acute Coronary Syndromes by Means of Optical Coherence Tomography and Coronary Flow Reserve
The purpose of this study is to compare vascular healing of the stented segment after deployment of titanium-nitride-oxide coated cobalt-chromium Optimax™-stent stent and Promus-Element™ everolimus-eluting stent in patients with acute coronary syndromes requiring percutaneous coronary intervention.
- Comparison of OCT and CFR findings of titanium-nitride-oxide coated cobalt-chromium Optimax™-stent and Promus-Element™ everolimus-eluting stent at two months after the index procedure.
- Comparison of intravascular coronary flow reserve measurement to non-invasive transthoracic echocardiography-derived coronary flow reserve measurement.
- Comparison of epicardial vasodilation to coronary microcirculatory vasodilation
- Conditions
- Acute Coronary Syndrome
- Being tested
- Stenting using Optimax™, Stenting using PROMUS Element™ Plus
- Keywords
- titanium-nitride-oxide-coated stent, everolimus-eluting stent, optical coherence tomography, strut coverage
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stenting using Optimax™Procedure or surgery
Stenting using PROMUS Element™ PlusProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| CoCr-BAS | Active comparator | Stenting using Optimax™ cobalt-chromium alloy platform with a titanium-nitride-oxide coating Receives: Procedure: Stenting using Optimax™ |
| PtCr-EES | Active comparator | Stenting using PROMUS Element™ Plus durable polymer everolimus-eluting stent built on a platinum-chromium platform. Receives: Procedure: Stenting using PROMUS Element™ Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of uncovered struts
Measured: 2 months
Secondary outcomes (1)
Coronary flow reserve
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startJan 2013
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital District of Satakunta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280720
- Sponsor's protocol ID
- SA-006
- Acronym
- TIDES-OCT
- Status last verified
- Oct 2014
- First submitted
- 29 Oct 2014
- Last updated
- 31 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Multicenter Trial to Compare Vascular Healing and Vasodilation at 2 Months After Deployment of TItanium-nitride-oxide-coated OPTIMAX™ Stent and PROMUS-ELEMENT™ Drug-Eluting Stent in Patients With Acute Coronary Syndromes by Means of Optical Coherence Tomography and Coronary Flow Reserve
- ClinicalTrials.gov ID
- NCT02280720
- Acronym / sponsor ID
- TIDES-OCT / SA-006
- Conditions
- Acute Coronary Syndrome
- Keywords
- titanium-nitride-oxide-coated stent, everolimus-eluting stent, optical coherence tomography, strut coverage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Hospital District of SatakuntaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 31 Oct 2014 (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.
The purpose of this study is to compare vascular healing of the stented segment after deployment of titanium-nitride-oxide coated cobalt-chromium Optimax™-stent stent and Promus-Element™ everolimus-eluting stent in patients with acute coronary syndromes requiring percutaneous coronary intervention.
- Comparison of OCT and CFR findings of titanium-nitride-oxide coated cobalt-chromium Optimax™-stent and Promus-Element™ everolimus-eluting stent at two months after the index procedure.
- Comparison of intravascular coronary flow reserve measurement to non-invasive transthoracic echocardiography-derived coronary flow reserve measurement.
- Comparison of epicardial vasodilation to coronary microcirculatory vasodilation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CoCr-BAS | Active comparator | Procedure: Stenting using Optimax™Stenting using Optimax™ cobalt-chromium alloy platform with a titanium-nitride-oxide coating |
| PtCr-EES | Active comparator | Procedure: Stenting using PROMUS Element™ PlusStenting using PROMUS Element™ Plus durable polymer everolimus-eluting stent built on a platinum-chromium platform. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age >18 and <80 years
- STEMI or NSTEMI (assumed by investigator to be type 1 myocardial infarction, according to universal definitions of MI; EHJ 2007; 28(20):2525-38); or unstable angina (clinical symptoms of chest pain, ecg suggestive of reversible ischemia)
- Patient is willing to comply with specified follow-up evaluations
- Patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics committee or Institutional Review Board
- Single de novo or non-stented restenosis lesion
Key exclusion criteria (18 listed)
- Pre-existing diagnosis of diabetes irrespective of its type
- Impaired renal function (serum creatinine >177micromol/l) or on dialysis
- Platelet count < 10 e5 cells/mm3
- Patient has a history of bleeding diathesis or coagulopathy or patients in whom antiplatelet and and/or anticoagulation therapy is contraindicated
- Patient has received organ transplant or is on a waiting list for any organ transplant
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 |
|---|---|---|
| Stenting using Optimax™ | Procedure or surgery | CoCr-BAS |
| Stenting using PROMUS Element™ Plus | Procedure or surgery | PtCr-EES |
Primary outcome
Percentage of uncovered struts
Time frame: 2 months
1 secondary outcome
Coronary flow reserve
Time frame: 2 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 31 Oct 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 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 Stenting using Optimax™ and Stenting using PROMUS Element™ Plus in people with Acute Coronary Syndrome, run by The Hospital District of Satakunta at 4 sites in Finland.
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 10 inclusion and 18 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 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland. 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?
Percentage of uncovered struts (time frame: 2 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 31 Oct 2014.