Optimal dRug Eluting steNts Implantation Guided By Intravascular Ultrasound and Optical coheRence tomoGraphy ORENBURG
- Conditions
- Coronary Artery DiseaseCoronary DiseaseHeart Diseases
- Interventions
- Procedure: IVUS-guided groupProcedure: Non-IVUS group
- Registration Number
- NCT01917201
- Lead Sponsor
- The Orenburg Regional Clinical Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- 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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IVUS-guided group IVUS-guided group 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. Non-IVUS group Non-IVUS group 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.
- Primary Outcome Measures
Name Time Method MACCE 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)
- Secondary Outcome Measures
Name Time Method Neo-Intimal Plaque Volume and Area 6 months, 2 years Neo-Intimal Plaque Volume and Area after 6 months and 2 years by OCT data
Uncovered struts of stents 6 months, 2 years Detection and calculation of number of uncovered struts after 6 months and 2 years by OCT data
Restenosis 6 months, two years Percentage of stenosis by angiography and OCT data (based on external elastic membrane (EEM))
In stent lumen late loss 6 months, 2 years Reduction of a lumen of artery after 6 months and 2 years after operation by OCT data
Stent Malapposition 6 months, 2 year Volume and Area of Stent Malapposition after 6 months and 2 years by OCT data
Trial Locations
- Locations (1)
The State Budgetary Establishment of Health "the Orenburg Regional Clinical Hospital"
🇷🇺Orenburg, Orenburg Region, Russian Federation