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

Coronary Artery Disease Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01917201
• Other study ID #: OCH01DV0713
• Status: Recruiting
• Phase: N/A
• First received: July 13, 2013
• Last updated: October 26, 2014
• Start date: March 2012
• Est. completion date: December 2016

Study information

• Verified date: October 2014
• Source: The Orenburg Regional Clinical Hospital
• Contact: Victor V Demin, MD, PhD
• Phone: +7 912 8462296
• Email: angiorenvd[@]mail.ru
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• 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

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Russian Federation	The State Budgetary Establishment of Health "the Orenburg Regional Clinical Hospital"	Orenburg	Orenburg Region

Sponsors (1)

Lead Sponsor	Collaborator
The Orenburg Regional Clinical Hospital

Country where clinical trial is conducted

Russian Federation, 

Outcome

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