"TransRadial Ultra Support Technique" (TRUST)

Not Applicable

Completed

• Conditions: Coronary Arterioscleroses; Coronary Artery Disease
• Interventions: Procedure: Anchoring Technique; Procedure: TRUST technique; Procedure: Coronary stenting

• Registration Number: NCT03025685
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-01-16
• Study First Posted: 2017-01-19
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-24
• Last Update Posted: 2017-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anchoring technique + Coronary Stenting	Anchoring Technique	PCI with coronary stenting using Wire Anchoring Pass technique for support improvement
TRUST technique + Coronary Stenting	TRUST technique	PCI with coronary stenting using TransRadial Ultra Support technique for support improvement
Anchoring technique + Coronary Stenting	Coronary stenting	PCI with coronary stenting using Wire Anchoring Pass technique for support improvement
TRUST technique + Coronary Stenting	Coronary stenting	PCI with coronary stenting using TransRadial Ultra Support technique for support improvement

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

State Research Institute of CIrculation Pathology; 🇷🇺 Novosibirsk, Russian Federation