"TransRadial Ultra Support Technique" (TRUST)

Meshalkin Research Institute of Pathology of Circulation

Status: Completed

Conditions: Coronary Artery Disease; Coronary Arterioscleroses

Treatments: Procedure: Coronary stenting; Procedure: Anchoring Technique; Procedure: TRUST technique

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT03025685

TRUST

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

TRUST technique + Coronary Stenting

Experimental group

Description:

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

Treatment:

Procedure: TRUST technique

Procedure: Coronary stenting

Anchoring technique + Coronary Stenting

Active Comparator group

Description:

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

Treatment:

Procedure: Coronary stenting

Procedure: Anchoring Technique