NCT03025685
Completed
Not Applicable
"TransRadial Ultra Support Technique" (TRUST Technique) Versus Anchoring Technique to Enhance Guiding Catheter Support: a Prospective Randomized Pilot Study
Meshalkin Research Institute of Pathology of Circulation1 site in 1 country54 target enrollmentStarted: September 2016Last updated:
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Procedural success
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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/mm
- •Known non-adherence to double anti-platelet therapy (DAPT)
- •LVEF \<30%
- •Continuing bleeding
- •Acute coronary syndrome (ST-elevation Myocardial infarction)
- •Pregnancy
Outcomes
Primary Outcomes
Procedural success
Time Frame: 1 week after PCI
Device success without the occurrence of in-hospital MACCE
Device success
Time Frame: Intraoperative
Achievement of a final residual diameter stenosis \<20% and a TIMI 3 flow in the target vessel
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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