"TransRadial Ultra Support Technique" (TRUST)

NCT03025685 | Completed

• 1 other identifier: TRUST
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Arterioscleroses; Coronary Artery Disease

Keywords

Percutaneous Coronary Intervention; Coronary Artery Disease; Wire; Coronary stenting

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

TRUST technique + Coronary Stenting

EXPERIMENTAL

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

Procedure: TRUST technique; Procedure: Coronary stenting

Anchoring technique + Coronary Stenting

ACTIVE COMPARATOR

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

Procedure: Anchoring Technique; Procedure: Coronary stenting

Interventions

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

TRUST technique + Coronary Stenting

Anchoring Technique PROCEDURE

A standard endovascular technique of coronary wire support improvement

Anchoring technique + Coronary Stenting

Coronary stenting PROCEDURE

A standard endovascular procedure of percutaneous coronary intervention with coronary stenting

Anchoring technique + Coronary Stenting; TRUST technique + Coronary Stenting

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

State Research Institute of CIrculation Pathology

Novosibirsk, 630055, Russia

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 19, 2017
• Study Start: September 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 27, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)