Coronary Artery DiseaseORENBURGNCT01917201
Optimal dRug Eluting steNts Implantation Guided By Intravascular Ultrasound and Optical coheRence tomoGraphy ORENBURG
A study testing IVUS-guided group and Non-IVUS group in people with Coronary Artery Disease and Coronary Disease, run by The Orenburg Regional Clinical Hospital at 1 site in Russia.
Trial summary
The objective of this research is to assess the clinical results of implantation of different drug eluting stents under "aggressive" intravascular ultrasound (IVUS) guided all the way up to 24 months after operation and to establish the significance of the data of an optical coherent tomography (OCT) for the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease, Coronary Disease, Heart Diseases
- What is being tested?
- IVUS-guided group and Non-IVUS group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteRussia
- Study dates
- Mar 2012to Dec 2016
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- de novo lesion,
- the diameter of a vessel is not less than 2,75 mm,
- the length of lesion not more than 60 mm,
- stenosis is more than 60 %,
- possibility of a covering by no more than 2 stents,
- there is no need in stenting of side branch (including left main coronary artery).
Who cannot join
- in-stent restenosis,
- saphenous vein grafts,
- the diameter of a vessel is less than 2,75 mm,
- the length of lesion more than 60 mm,
- there is a need in stenting of side branch (including left main coronary artery),
- impossibility of long antiplatelet therapy,
- impossibility of an appearance for control research
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
The State Budgetary Establishment of Health "the Orenburg Regional Clinical Hospital"
Orenburg, Orenburg Oblast, 460018
Victor V Demin, MD, PhD, +7 912 8462296, angiorenvd@mail.ru
Victor V Demin, MD, PhD
About this study
Official title: Prospective, Single-center, Randomized Trial, Intended to Compare of Intravascular Ultrasound and Optical Coherence Tomography Guided Implantation of Different Drug-eluting Stents and Implantation Without Using of Intravascular Visualization
The objective of this research is to assess the clinical results of implantation of different drug eluting stents under "aggressive" intravascular ultrasound (IVUS) guided all the way up to 24 months after operation and to establish the significance of the data of an optical coherent tomography (OCT) for the assessment of direct results of stenting and the degrees of endothelization of stent after 6 months.
The following hypothesis formed the base for this study:
- IVUS guided intervention allows to improve the results and increase the safety of implantation drug eluting stents.
- Suboptimal results according to IVUS data can influence the follow up results of treatment.
- Suboptimal results according to OCT data, which are not revealed by IVUS, can influence the follow up results of treatment.
- The use of strategy of stenting with the achievement of optimal results under the intravascular methods of visualization allows to reduce the time of application of antiplatelet therapy.
- The modern limus-eluting stents do not differ in the follow up results in investigated criteria.
Read the detailed description
1000 consecutive patients are planned to be included who will underwent endovascular treatment answering for the inclusion criteria and having given informed consent to the inclusion in the study.
Criteria for choosing the size of the stent according to the IVUS:
- Support on the healthy parts of the vessel.
- The diameter of the stent should match the diameter of "media-media" in the distal reference segment or be the average between the diameter of the lumen of the proximal and distal reference segments.
- Postdilatation is sure to be in the stent: in the affected area by a large balloon over the initial diameter of the "media-media", at the entrance of the stent - over the initial of the reference diameter of the lumen.
After postdilatation a control is being performed with "Virtual Histology" (VH) IVUS and i-MAP, an optimal stent implantation is estimated.
Criteria for optimal implantation:
- Complete apposition around the entire circumference.
- Symmetry index is more than 0.75.
- Stent diameter is not less than 80% of nominal.
- Lack of initial dissection at the edges of the stent.
- Lack of prolapsed tissue.
A comparison of all the data is carried out by groups with and without using of IVUS and by types of the stents, as well as by groups according to intraoperative results: (a) the optimal result by IVUS and OCT, (b) optimal result by IVUS; suboptimal - by OCT, (c) suboptimal results with IVUS and OCT, as well as in subgroups of optimal (d) and suboptimal (e) results by OCT in patients without IVUS.
- Conditions
- Coronary Artery Disease, Coronary Disease, Heart Diseases
- Being tested
- IVUS-guided group, Non-IVUS group
- Keywords
- Coronary Artery Disease, Drug Eluting Stents, Intravascular Ultrasound, Optical Coherence Tomography, Intravascular Visualization
- Medical subject headings
- Coronary Artery Disease, Coronary Disease, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVUS-guided groupProcedure or surgery
Also called IVUS-guided DES implantation with OCT control.
The randomization on groups was completed in accordance with stents to be implanted: "Xience Prime"/"Xience V", "Promus Element", "Resolute Integrity", "Biomatrix Flex", "Nobori", "Orsiro". In each group randomization on subgroups of IVUS-guided implantation and non-IVUS in the ratio 2:1 was completed. After randomization it is carried out coronary stenting under IVUS-control: a choice of length and diameter of stent - according to IVUS data. After the completion of implantation and postdilatation of stents the control IVUS is being used. If criteria of optimal implantation were not achieved, additional impact is being made: larger balloon, higher pressure, sufficient time of impact. In case of an additional impact the repeated control IVUS is being completed and the following results are being fixed. After control IVUS the OCT procedure is carried out. During OCT possible problems corresponding to stenting are being fixed. An additional impact based on OCT data is not being used.
Non-IVUS groupProcedure or surgery
Also called Angiography-guided DES implantation with OCT control
The randomization on groups was completed in accordance with stents to be implanted: "Xience Prime"/"Xience V", "Promus Element", "Resolute Integrity", "Biomatrix Flex", "Nobori", "Orsiro". In each group randomization on subgroups of IVUS-guided implantation and non-IVUS in the ratio 2:1 was completed. After randomization it is carried out coronary stenting under angiography control. After postdilatation control OCT is carried out. During OCT possible problems corresponding to stenting (malapposed struts, separate beams, a prolapse of fiber, microthrombosis) are being fixed. An additional impact based on OCT data is not being used.
| Study group | Role | What they receive |
|---|---|---|
| IVUS-guided group | Other | The coronary stenting under IVUS-control (with VH or i-MAP) is carried out: a choice of length and diameter of stent - according to IVUS data. After the completion of implantation and postdilatation of stents the control IVUS (with VH or i-MAP) is being used, the optimality of stent implantation is also being assessed.If criteria of optimal implantation guided by IVUS were not achieved, additional impact is being made. In case of an additional impact the repeated control IVUS is being completed and the following results are being fixed. After control IVUS the OCT procedure is carried out. An additional impact based on OCT data is not being used. Receives: Procedure: IVUS-guided group |
| Non-IVUS group | Other | The coronary stenting under angiography control is carried out. After postdilatation control OCT is carried out. An additional impact based on OCT data is not being used. Receives: Procedure: Non-IVUS group |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACCE
Major adverse cardiac and cerebral events (MACCE), including death, a composite of major cardiac and cerebrovascular events, i.e. the first occurence of any of the following events:
Death from any cause - From cardiovascular causes, From noncardiovascular causes; Stroke or transitory ischemic attack (TIA), Myocardial infarction (MI), Hospitalization for repeat revascularization procedure, target vessel revascularization by means of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
Measured: Two years
Secondary outcomes (5)
Restenosis
Percentage of stenosis by angiography and OCT data (based on external elastic membrane (EEM))
Measured: 6 months, two years
In stent lumen late loss
Reduction of a lumen of artery after 6 months and 2 years after operation by OCT data
Measured: 6 months, 2 years
Stent Malapposition
Volume and Area of Stent Malapposition after 6 months and 2 years by OCT data
Measured: 6 months, 2 year
Neo-Intimal Plaque Volume and Area
Neo-Intimal Plaque Volume and Area after 6 months and 2 years by OCT data
Measured: 6 months, 2 years
Uncovered struts of stents
Detection and calculation of number of uncovered struts after 6 months and 2 years by OCT data
Measured: 6 months, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startMar 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Orenburg Regional Clinical Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Victor V Demin, MD, PhD, Principal investigator, THE HEAD OF INTERVENTIONAL CARDIOLOGY AND ANGIOLOGY DEPARTMENT OF THE STATE BUDGETARY ESTABLISHMENT OF HEALTH "THE ORENBURG REGIONAL CLINICAL HOSPITAL"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917201
- Sponsor's protocol ID
- OCH01DV0713
- Acronym
- ORENBURG
- Status last verified
- Oct 2014
- First submitted
- 13 Jul 2013
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-center, Randomized Trial, Intended to Compare of Intravascular Ultrasound and Optical Coherence Tomography Guided Implantation of Different Drug-eluting Stents and Implantation Without Using of Intravascular Visualization
- ClinicalTrials.gov ID
- NCT01917201
- Acronym / sponsor ID
- ORENBURG / OCH01DV0713
- Conditions
- Coronary Artery Disease, Coronary Disease, Heart Diseases
- Keywords
- Coronary Artery Disease, Drug Eluting Stents, Intravascular Ultrasound, Optical Coherence Tomography, Intravascular Visualization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The Orenburg Regional Clinical HospitalOther government
- Study start
- Mar 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 6 Aug 2013 (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 objective of this research is to assess the clinical results of implantation of different drug eluting stents under "aggressive" intravascular ultrasound (IVUS) guided all the way up to 24 months after operation and to establish the significance of the data of an optical coherent tomography (OCT) for the assessment of direct results of stenting and the degrees of endothelization of stent after 6 months.
The following hypothesis formed the base for this study:
- IVUS guided intervention allows to improve the results and increase the safety of implantation drug eluting stents.
- Suboptimal results according to IVUS data can influence the follow up results of treatment.
- Suboptimal results according to OCT data, which are not revealed by IVUS, can influence the follow up results of treatment.
- The use of strategy of stenting with the achievement of optimal results under the intravascular methods of visualization allows to reduce the time of application of antiplatelet therapy.
- The modern limus-eluting stents do not differ in the follow up results in investigated criteria.
Detailed description
1000 consecutive patients are planned to be included who will underwent endovascular treatment answering for the inclusion criteria and having given informed consent to the inclusion in the study.
Criteria for choosing the size of the stent according to the IVUS:
- Support on the healthy parts of the vessel.
- The diameter of the stent should match the diameter of "media-media" in the distal reference segment or be the average between the diameter of the lumen of the proximal and distal reference segments.
- Postdilatation is sure to be in the stent: in the affected area by a large balloon over the initial diameter of the "media-media", at the entrance of the stent - over the initial of the reference diameter of the lumen.
After postdilatation a control is being performed with "Virtual Histology" (VH) IVUS and i-MAP, an optimal stent implantation is estimated.
Criteria for optimal implantation:
- Complete apposition around the entire circumference.
- Symmetry index is more than 0.75.
- Stent diameter is not less than 80% of nominal.
- Lack of initial dissection at the edges of the stent.
- Lack of prolapsed tissue.
A comparison of all the data is carried out by groups with and without using of IVUS and by types of the stents, as well as by groups according to intraoperative results: (a) the optimal result by IVUS and OCT, (b) optimal result by IVUS; suboptimal - by OCT, (c) suboptimal results with IVUS and OCT, as well as in subgroups of optimal (d) and suboptimal (e) results by OCT in patients without IVUS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVUS-guided group | Other | Procedure: IVUS-guided groupThe coronary stenting under IVUS-control (with VH or i-MAP) is carried out: a choice of length and diameter of stent - according to IVUS data. After the completion of implantation and postdilatation of stents the control IVUS (with VH or i-MAP) is being used, the optimality of stent implantation is also being assessed.If criteria of optimal implantation guided by IVUS were not achieved, additional impact is being made. In case of an additional impact the repeated control IVUS is being completed and the following results are being fixed. After control IVUS the OCT procedure is carried out. An additional impact based on OCT data is not being used. |
| Non-IVUS group | Other | Procedure: Non-IVUS groupThe coronary stenting under angiography control is carried out. After postdilatation control OCT is carried out. An additional impact based on OCT data is not being used. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- de novo lesion,
- the diameter of a vessel is not less than 2,75 mm,
- the length of lesion not more than 60 mm,
- stenosis is more than 60 %,
- possibility of a covering by no more than 2 stents,
Key exclusion criteria (7 listed)
- in-stent restenosis,
- saphenous vein grafts,
- the diameter of a vessel is less than 2,75 mm,
- the length of lesion more than 60 mm,
- there is a need in stenting of side branch (including left main coronary artery),
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 |
|---|---|---|
| IVUS-guided groupAlso: IVUS-guided DES implantation with OCT control.The randomization on groups was completed in accordance with stents to be implanted: "Xience Prime"/"Xience V", "Promus Element", "Resolute Integrity", "Biomatrix Flex", "Nobori", "Orsiro". In each group randomization on subgroups of IVUS-guided implantation and non-IVUS in the ratio 2:1 was completed. After randomization it is carried out coronary stenting under IVUS-control: a choice of length and diameter of stent - according to IVUS data. After the completion of implantation and postdilatation of stents the control IVUS is being used. If criteria of optimal implantation were not achieved, additional impact is being made: larger balloon, higher pressure, sufficient time of impact. In case of an additional impact the repeated control IVUS is being completed and the following results are being fixed. After control IVUS the OCT procedure is carried out. During OCT possible problems corresponding to stenting are being fixed. An additional impact based on OCT data is not being used. | Procedure or surgery | IVUS-guided group |
| Non-IVUS groupAlso: Angiography-guided DES implantation with OCT controlThe randomization on groups was completed in accordance with stents to be implanted: "Xience Prime"/"Xience V", "Promus Element", "Resolute Integrity", "Biomatrix Flex", "Nobori", "Orsiro". In each group randomization on subgroups of IVUS-guided implantation and non-IVUS in the ratio 2:1 was completed. After randomization it is carried out coronary stenting under angiography control. After postdilatation control OCT is carried out. During OCT possible problems corresponding to stenting (malapposed struts, separate beams, a prolapse of fiber, microthrombosis) are being fixed. An additional impact based on OCT data is not being used. | Procedure or surgery | Non-IVUS group |
Primary outcome
MACCE
Time frame: Two years
Major adverse cardiac and cerebral events (MACCE), including death, a composite of major cardiac and cerebrovascular events, i.e. the first occurence of any of the following events: Death from any cause - From cardiovascular causes, From noncardiovascular causes; Stroke or transitory ischemic attack (TIA), Myocardial infarction (MI), Hospitalization for repeat revascularization procedure, target vessel revascularization by means of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
5 secondary outcomes
Restenosis
Time frame: 6 months, two years
In stent lumen late loss
Time frame: 6 months, 2 years
Stent Malapposition
Time frame: 6 months, 2 year
Neo-Intimal Plaque Volume and Area
Time frame: 6 months, 2 years
Uncovered struts of stents
Time frame: 6 months, 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 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.
Victor V Demin, MD, PhD principal investigator
THE HEAD OF INTERVENTIONAL CARDIOLOGY AND ANGIOLOGY DEPARTMENT OF THE STATE BUDGETARY ESTABLISHMENT OF HEALTH "THE ORENBURG REGIONAL CLINICAL HOSPITAL"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVUS-guided group and Non-IVUS group in people with Coronary Artery Disease and Coronary Disease, run by The Orenburg Regional Clinical Hospital at 1 site in Russia.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 28 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 1 site in Russia. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Victor V Demin, MD, PhD (+7 912 8462296, angiorenvd@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACCE (time frame: Two years). 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 28 Oct 2014.