"TransRadial Ultra Support Technique" (TRUST)

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Coronary Arterioscleroses
• Intervention / Treatment: Procedure: TRUST technique; Procedure: Coronary stenting; Procedure: Anchoring Technique

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630055
    • State Research Institute of Circulation Pathology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects singed informed consent form
• Subjects eligible for percutaneous coronary intervention

Exclusion Criteria:

• Age <18 years or >75 years
• Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
• Known non-adherence to double anti-platelet therapy (DAPT)
• LVEF <30%
• Continuing bleeding
• Acute coronary syndrome (ST-elevation Myocardial infarction)
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: Coronary stenting; A standard endovascular procedure of percutaneous coronary intervention with coronary stenting; Procedure: Anchoring Technique; A standard endovascular technique of coronary wire support improvement

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Meshalkin Research Institute of Pathology of Circulation

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: January 12, 2017
• First Submitted That Met QC Criteria: January 16, 2017
• First Posted (Estimate): January 19, 2017

Study Record Updates

• Last Update Posted (Actual): December 27, 2017
• Last Update Submitted That Met QC Criteria: December 24, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Percutaneous Coronary Intervention; Wire; Coronary stenting
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Arteriosclerosis
• Other Study ID Numbers: TRUST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO