Optimal dRug Eluting steNts Implantation Guided By Intravascular Ultrasound and Optical coheRence tomoGraphy ORENBURG

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.

Conditions

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases

Interventions

PROCEDURE

IVUS-guided group

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

Non-IVUS group

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.

Sponsors & Collaborators

• The Orenburg Regional Clinical Hospital

  lead OTHER_GOV

Principal Investigators

• 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"

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-03-31

Primary Completion

2014-12-31

Completion

2016-12-31

Countries

• Russia

Study Locations