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

Coronary Artery Disease Clinical Trial

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

Status Recruiting

Clinical 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 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

• NCT number: NCT01917201
• Study type: Interventional
• Source: The Orenburg Regional Clinical Hospital
• Contact: Victor V Demin, MD, PhD
• Phone: +7 912 8462296
• Email: angiorenvd@mail.ru
• Status: Recruiting
• Phase: N/A
• Start date: March 2012
• Completion date: December 2016