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

The Orenburg Regional Clinical Hospital

Status: Unknown

Conditions: Coronary Artery Disease; Heart Diseases; Coronary Disease

Treatments: Procedure: Non-IVUS group; Procedure: IVUS-guided group

Study type: Interventional

Funder types: Other

Identifiers

NCT01917201

OCH01DV0713

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

IVUS-guided group

Other group

Description:

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.

Treatment:

Procedure: IVUS-guided group

Non-IVUS group

Other group

Description:

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.

Treatment:

Procedure: Non-IVUS group