Clinical trial NCT01917201: Optimal dRug Eluting steNts Implantation Guided By Intravascular Ultrasound and Optical coheRence tomoGraphy ORENBURG
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Coronary Disease
Heart Diseases
Keywords: Coronary Artery Disease
Drug Eluting Stents
Intravascular Ultrasound
Optical Coherence Tomography
Intravascular Visualization
Lead sponsor: The Orenburg Regional Clinical Hospital
Sponsor class: OTHER_GOV
First posted: 2013-08-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: MACCE
timeFrame: Two years
Secondary outcomes:
measure: Restenosis
timeFrame: 6 months, two years
measure: In stent lumen late loss
timeFrame: 6 months, 2 years
measure: Stent Malapposition
timeFrame: 6 months, 2 year
measure: Neo-Intimal Plaque Volume and Area
timeFrame: 6 months, 2 years
measure: Uncovered struts of stents
timeFrame: 6 months, 2 years
Other outcomes:
Locations:
city: Orenburg
country: Russian Federation
facility: The State Budgetary Establishment of Health "the Orenburg Regional Clinical Hospital"
state: Orenburg Region
Study officials:
affiliation: THE HEAD OF INTERVENTIONAL CARDIOLOGY AND ANGIOLOGY DEPARTMENT OF THE STATE BUDGETARY ESTABLISHMENT OF HEALTH "THE ORENBURG REGIONAL CLINICAL HOSPITAL"
name: Victor V Demin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: