Back to results"TransRadial Ultra Support Technique" (TRUST)
Primary Purpose
Coronary Arterioscleroses, Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
TRUST technique
Anchoring Technique
Coronary stenting
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Arterioscleroses focused on measuring Percutaneous Coronary Intervention, Coronary Artery Disease, Wire, Coronary stenting
Eligibility Criteria
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
Sites / Locations
- State Research Institute of CIrculation Pathology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TRUST technique + Coronary Stenting
Anchoring technique + Coronary Stenting
Arm Description
PCI with coronary stenting using TransRadial Ultra Support technique for support improvement
PCI with coronary stenting using Wire Anchoring Pass technique for support improvement
Outcomes
Primary Outcome Measures
Procedural success
Device success without the occurrence of in-hospital MACCE
Device success
Achievement of a final residual diameter stenosis <20% and a TIMI 3 flow in the target vessel
Secondary Outcome Measures
Full Information
NCT ID
NCT03025685
First Posted
January 12, 2017
Last Updated
December 24, 2017
Sponsor
Meshalkin Research Institute of Pathology of Circulation
1. Study Identification
Unique Protocol Identification Number
NCT03025685
Brief Title
"TransRadial Ultra Support Technique" (TRUST)
Official Title
"TransRadial Ultra Support Technique" (TRUST Technique) Versus Anchoring Technique to Enhance Guiding Catheter Support: a Prospective Randomized Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Arterioscleroses, Coronary Artery Disease
Keywords
Percutaneous Coronary Intervention, Coronary Artery Disease, Wire, Coronary stenting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TRUST technique + Coronary Stenting
Arm Type
Experimental
Arm Description
PCI with coronary stenting using TransRadial Ultra Support technique for support improvement
Arm Title
Anchoring technique + Coronary Stenting
Arm Type
Active Comparator
Arm Description
PCI with coronary stenting using Wire Anchoring Pass technique for support improvement
Intervention Type
Procedure
Intervention Name(s)
TRUST technique
Intervention Description
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
Intervention Name(s)
Anchoring Technique
Intervention Description
A standard endovascular technique of coronary wire support improvement
Intervention Type
Procedure
Intervention Name(s)
Coronary stenting
Intervention Description
A standard endovascular procedure of percutaneous coronary intervention with coronary stenting
Primary Outcome Measure Information:
Title
Procedural success
Description
Device success without the occurrence of in-hospital MACCE
Time Frame
1 week after PCI
Title
Device success
Description
Achievement of a final residual diameter stenosis <20% and a TIMI 3 flow in the target vessel
Time Frame
Intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
State Research Institute of CIrculation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
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"TransRadial Ultra Support Technique" (TRUST)
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