"TransRadial Ultra Support Technique" (TRUST)

NCT ID: NCT03025685

Last Updated: 2017-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2016-12-31

Brief Summary

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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

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Conditions

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Coronary Arterioscleroses Coronary Artery Disease

Keywords

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Percutaneous Coronary Intervention Coronary Artery Disease Wire Coronary stenting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TRUST technique + Coronary Stenting

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

Group Type EXPERIMENTAL

TRUST technique

Intervention Type PROCEDURE

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

Coronary stenting

Intervention Type PROCEDURE

A standard endovascular procedure of percutaneous coronary intervention with coronary stenting

Anchoring technique + Coronary Stenting

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

Group Type ACTIVE_COMPARATOR

Anchoring Technique

Intervention Type PROCEDURE

A standard endovascular technique of coronary wire support improvement

Coronary stenting

Intervention Type PROCEDURE

A standard endovascular procedure of percutaneous coronary intervention with coronary stenting

Interventions

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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

Intervention Type PROCEDURE

Anchoring Technique

A standard endovascular technique of coronary wire support improvement

Intervention Type PROCEDURE

Coronary stenting

A standard endovascular procedure of percutaneous coronary intervention with coronary stenting

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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State Research Institute of CIrculation Pathology

Novosibirsk, , Russia

Site Status

Countries

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Russia

Other Identifiers

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TRUST

Identifier Type: -

Identifier Source: org_study_id