Optimal dRug Eluting steNts Implantation Guided By Intravascular Ultrasound and Optical coheRence tomoGraphy ORENBURG
ORENBURG
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
1 other identifier
interventional
1,000
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable coronary-artery-disease
Started Mar 2012
Typical duration for not_applicable coronary-artery-disease
1 active site
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
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 13, 2013
CompletedFirst Posted
Study publicly available on registry
August 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedOctober 28, 2014
October 1, 2014
2.8 years
July 13, 2013
October 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Two years
Secondary Outcomes (5)
Restenosis
6 months, two years
In stent lumen late loss
6 months, 2 years
Stent Malapposition
6 months, 2 year
Neo-Intimal Plaque Volume and Area
6 months, 2 years
Uncovered struts of stents
6 months, 2 years
Study Arms (2)
IVUS-guided group
OTHERThe 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
OTHERThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The State Budgetary Establishment of Health "the Orenburg Regional Clinical Hospital"
Orenburg, Orenburg Oblast, 460018, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Victor V Demin, MD, PhD
THE HEAD OF INTERVENTIONAL CARDIOLOGY AND ANGIOLOGY DEPARTMENT OF THE STATE BUDGETARY ESTABLISHMENT OF HEALTH "THE ORENBURG REGIONAL CLINICAL HOSPITAL"
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2013
First Posted
August 6, 2013
Study Start
March 1, 2012
Primary Completion
December 1, 2014
Study Completion
December 1, 2016
Last Updated
October 28, 2014
Record last verified: 2014-10