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"TransRadial Ultra Support Technique" (TRUST)

M

Meshalkin Research Institute of Pathology of Circulation

Status

Completed

Conditions

Coronary Artery Disease
Coronary Arterioscleroses

Treatments

Procedure: Coronary stenting
Procedure: Anchoring Technique
Procedure: TRUST technique

Study type

Interventional

Funder types

NETWORK

Identifiers

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

54 participants in 2 patient groups

TRUST technique + Coronary Stenting
Experimental group
Description:
PCI with coronary stenting using TransRadial Ultra Support technique for support improvement
Treatment:
Procedure: TRUST technique
Procedure: Coronary stenting
Anchoring technique + Coronary Stenting
Active Comparator group
Description:
PCI with coronary stenting using Wire Anchoring Pass technique for support improvement
Treatment:
Procedure: Anchoring Technique
Procedure: Coronary stenting

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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