Skip to main content
OpenTrials
Completed

NCT Number: NCT03025685

"TransRadial Ultra Support Technique" (TRUST)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Arterioscleroses Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

State Research Institute of CIrculation Pathology

Novosibirsk, 630055, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TRUST technique

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

Anchoring Technique

Procedure

A standard endovascular technique of coronary wire support improvement

Coronary stenting

Procedure

A standard endovascular procedure of percutaneous coronary intervention with coronary stenting

Primary outcomes

  1. Procedural success

    Time frame: 1 week after PCI

    Device success without the occurrence of in-hospital MACCE

  2. Device success

    Time frame: Intraoperative

    Achievement of a final residual diameter stenosis <20% and a TIMI 3 flow in the target vessel

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 19, 2017
Registry last updated
Dec 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.