"TransRadial Ultra Support Technique" (TRUST)

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03025685
• Other study ID #: TRUST
• Status: Completed
• Phase: N/A
• First received: January 12, 2017
• Last updated: December 24, 2017
• Start date: September 2016
• Est. completion date: December 2016

Study information

• Verified date: December 2017
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arterioscleroses
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• 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
• Anchoring Technique
A standard endovascular technique of coronary wire support improvement
• Coronary stenting
A standard endovascular procedure of percutaneous coronary intervention with coronary stenting

Locations

Country	Name	City	State
Russian Federation	State Research Institute of CIrculation Pathology	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural success	Device success without the occurrence of in-hospital MACCE	1 week after PCI
Primary	Device success	Achievement of a final residual diameter stenosis <20% and a TIMI 3 flow in the target vessel	Intraoperative