Coronary Artery Disease Clinical Trial
— ORENBURGOfficial 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.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | December 2016 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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). Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Russian Federation | The State Budgetary Establishment of Health "the Orenburg Regional Clinical Hospital" | Orenburg | Orenburg Region |
Lead Sponsor | Collaborator |
---|---|
The Orenburg Regional Clinical Hospital |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | Restenosis | Percentage of stenosis by angiography and OCT data (based on external elastic membrane (EEM)) | 6 months, two years | Yes |
Secondary | In stent lumen late loss | Reduction of a lumen of artery after 6 months and 2 years after operation by OCT data | 6 months, 2 years | No |
Secondary | Stent Malapposition | Volume and Area of Stent Malapposition after 6 months and 2 years by OCT data | 6 months, 2 year | No |
Secondary | Neo-Intimal Plaque Volume and Area | Neo-Intimal Plaque Volume and Area after 6 months and 2 years by OCT data | 6 months, 2 years | No |
Secondary | Uncovered struts of stents | Detection and calculation of number of uncovered struts after 6 months and 2 years by OCT data | 6 months, 2 years | No |
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