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Resting Full-cycle Ratio-guided Step by Step Balloon Dilation

NCT05107024 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-11-04

No results posted yet for this study

Summary

Drug-coated balloon (DCB), as an implant-free treatment technique, has been widely used in coronary interventional therapy, effectively solving the problem of restenosis caused by traditional stent implantation, and providing a treatment option for patients with coronary heart disease with high blood risk. However, in DCB treatment of coronary artery lesions, the incidence of dissection is as high as 10-20% when the balloon is predilated, which often requires salvage stent implantation, resulting in the treatment failure of DCB and bringing great hidden dangers to patients. The main reason was that excessive balloon predilation was caused by the standard of vascular anatomy (residual lumen stenosis less than 30%). The resting full cycle ratio (RFR) is a reliable method for determining the presence of functional ischemia in coronary artery lesions and enables immediate detection. We hypothesized that RFR-guided stepped-balloon dilation could reduce the incidence of dissection and increase the success rate of DCB treatment. Fifty patients who planned to receive DCB treatment were randomly divided into balloon dilation alone (n=25) and RFR-guided stepped-balloon dilation group (n=25). The primary endpoint was the success rate of DCB treatment. This study will provide a functional evaluation based balloon predilation method for DCB treatment, making DCB treatment for orthotopic coronary artery disease more safe and effective.

Conditions

  • de Novo Coronary Lesions

Interventions

DEVICE

RFR-guided step by step balloon dilation

The mean value of the minimum ratio of distal mean pressure to aortic mean pressure (Pd/Pa) in five consecutive complete cardiac cycles was obtained by scanning the diastolic and systolic stages at rest.

DEVICE

Traditional balloon dilation

The surgeon determines the optimal size of the semi-compliant balloon based on angiography (balloon to vessel ratio 1.0) and performs adequate predilation to achieve residual stenosis. 30% of vascular anatomy criteria

Sponsors & Collaborators

  • Shenzhen People's Hospital

    lead OTHER

Principal Investigators

  • Shaohong Dong · Shenzhen People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-11-30
Completion
2023-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05107024 on ClinicalTrials.gov