"TransRadial Ultra Support Technique" (TRUST)

Sponsor

Meshalkin Research Institute of Pathology of Circulation (Other)

Overall Status

Completed

CT.gov ID

NCT03025685

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

18.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Adequate support is required for challenging percutaneous coronary interventions (PCI). The "TransRadial Ultra Support Technique" (TRUST technique) is a new support technique that provides active support by deep pass of the coronary wire into the heart cavities (left ventricle-LV, right ventricle-RV) or aorta.

Condition or Disease	Intervention/Treatment	Phase
Coronary Arterioscleroses Coronary Artery Disease	Procedure: TRUST technique Procedure: Anchoring Technique Procedure: Coronary stenting	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

"TransRadial Ultra Support Technique" (TRUST Technique) Versus Anchoring Technique to Enhance Guiding Catheter Support: a Prospective Randomized Pilot Study

Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TRUST technique + Coronary Stenting PCI with coronary stenting using TransRadial Ultra Support technique for support improvement	Procedure: TRUST technique A soft hydrophilic wire easily pass through the invisible small vessels in the distal parts of a coronary artery into a heart cavity. It is necessary to pass a wire softly and forward as deep as possible. Quite often the wire goes through the left ventricle to aorta arch, and sometimes distal soft tip can be visible in a descending aorta. Thus the stiffest part of the wire become staying on all length of artery, straightening bends and giving the maximum support. After that balloons and stents can be delivered more easily Procedure: Coronary stenting A standard endovascular procedure of percutaneous coronary intervention with coronary stenting
Active Comparator: Anchoring technique + Coronary Stenting PCI with coronary stenting using Wire Anchoring Pass technique for support improvement	Procedure: Anchoring Technique A standard endovascular technique of coronary wire support improvement Procedure: Coronary stenting A standard endovascular procedure of percutaneous coronary intervention with coronary stenting

Arm

Intervention/Treatment

Experimental: TRUST technique + Coronary Stenting

PCI with coronary stenting using TransRadial Ultra Support technique for support improvement

Procedure: TRUST technique

A soft hydrophilic wire easily pass through the invisible small vessels in the distal parts of a coronary artery into a heart cavity. It is necessary to pass a wire softly and forward as deep as possible. Quite often the wire goes through the left ventricle to aorta arch, and sometimes distal soft tip can be visible in a descending aorta. Thus the stiffest part of the wire become staying on all length of artery, straightening bends and giving the maximum support. After that balloons and stents can be delivered more easily

Procedure: Coronary stenting

A standard endovascular procedure of percutaneous coronary intervention with coronary stenting

Active Comparator: Anchoring technique + Coronary Stenting

PCI with coronary stenting using Wire Anchoring Pass technique for support improvement

Procedure: Anchoring Technique

A standard endovascular technique of coronary wire support improvement

Procedure: Coronary stenting

A standard endovascular procedure of percutaneous coronary intervention with coronary stenting

Outcome Measures

Primary Outcome Measures

Procedural success [1 week after PCI]
Device success without the occurrence of in-hospital MACCE
Device success [Intraoperative]
Achievement of a final residual diameter stenosis <20% and a TIMI 3 flow in the target vessel