"TransRadial Ultra Support Technique" (TRUST)
Not Applicable
Completed
- Conditions
- Coronary ArteriosclerosesCoronary Artery Disease
- Registration Number
- NCT03025685
- Lead Sponsor
- Meshalkin Research Institute of Pathology of Circulation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Procedural success 1 week after PCI Device success without the occurrence of in-hospital MACCE
Device success Intraoperative Achievement of a final residual diameter stenosis \<20% and a TIMI 3 flow in the target vessel
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
State Research Institute of CIrculation Pathology
🇷🇺Novosibirsk, Russian Federation
State Research Institute of CIrculation Pathology🇷🇺Novosibirsk, Russian Federation