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

NCT05107024 | Unknown

• 1 other identifier: Shenzhen REDUCE
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Success rate of DCB treatment

  Successful DCB treatment was defined as the use of DCB-releasing agents in the treatment of orthotopic coronary artery disease without the need for salvage stent implantation during surgery and hospitalization

  During sample collection (1 year)

Secondary Outcomes (2)

• Incidence of adverse cardiac events (MACE)

  2 years

• Incidence of late lumen loss

  2 years

Study Arms (2)

Traditional balloon dilation group

ACTIVE COMPARATOR

The optimal size of the semi-compliant balloon (balloon to vessel ratio 1.0) was determined by the surgeon according to angiography, and sufficient predilation was performed to achieve residual stenosis. 30% vascular anatomy criteria, and then a 1:1 DCB was selected for drug release

Device: Traditional balloon dilation

RFR-guided step by step balloon dilation group

EXPERIMENTAL

Balloon dilation start with 2.0mm compliant balloon. After 8atm pressure expansion, the RFR value was measured. If RFR≥0.93, the pre-expansion was stopped. Otherwise, RFR value is measured after pressure expansion of 16atm, if RFR value is still less than 0.93, then a 2.5mm compliant or non-compliant balloon was used to expand the pressure of 8ATM, and the balloon diameter and expansion pressure were continuously increased until RFR≥0.93. Then a DCB with the same diameter as the pre-expanded balloon was selected for drug release.

Device: RFR-guided step by step balloon dilation

Interventions

RFR-guided step by step balloon dilation DEVICE

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.

RFR-guided step by step balloon dilation group

Traditional balloon dilation DEVICE

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

Traditional balloon dilation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years old; Presenting with stable or unstable angina and/or evidence of myocardial ischemia; The treated lesions were in situ coronary artery lesions. Angiography showed lumen diameter of 2.5-4.0mm and diameter stenosis ≥80%. No more than 2 lesions require treatment.

You may not qualify if:

• Acute myocardial infarction within 48 hours of onset; Life expectancy of less than 12 months; Lesion in left main trunk, lesion length \> 24mm, severe calcification, thrombosis or bifurcation; There are other lesions that require stenting.

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Officials

• Shaohong Dong

  Shenzhen People's Hospital

  STUDY CHAIR

Central Study Contacts

Xin Sun

CONTACT

+86-755-22943205; sunxinflying@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 4, 2021
• Study Start: December 1, 2021
• Primary Completion: November 30, 2022
• Study Completion: December 1, 2023
• Last Updated: November 4, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share