Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05107024 |
| Other study ID # |
Shenzhen REDUCE |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2021 |
| Est. completion date |
December 1, 2023 |
Study information
| Verified date |
October 2021 |
| Source |
Shenzhen People's Hospital |
| Contact |
Xin Sun |
| Phone |
+86-755-22943205 |
| Email |
sunxinflying[@]163.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
To compare the application of pre-treated lesions with DCB in the treatment of coronary
artery disease in situ between the simple balloon dilation group and rFR-guided
stepped-balloon dilation group.
It was a single-center, open, prospective, randomized controlled study. Fifty patients with
symptoms of myocardial ischemia or relevant evidence for DCB treatment of coronary artery
disease in situ were enrolled and randomly divided into balloon dilation group alone (n=25)
and rFR-guided step balloon dilation group (n=25).
In the balloon dilation group, the optimal size of the semi-compliant balloon was determined
by the surgeon according to angiography (the ratio of balloon to blood vessel was 1.0), and
full predilation was performed to achieve residual stenosis. 30% vascular anatomy criteria,
and then a 1:1 DCB was selected for drug release; The step balloon expansion group guided by
RFR expanded from 2.0mm compliant balloon. After 8atm pressure expansion, the RFR value was
measured. If RFR≥0.93, the pre-expansion was stopped. 0.93, RFR value is measured after
pressure expansion of 16atm, if RFR< is still; 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, and then A DCB with the same
diameter as the pre-expanded balloon was selected for drug release. If c-type or higher
dissection or TIMI flow occurs & LT; Grade 3 patients were given salvage stents.
Collect patient history and improve clinical examination; The occurrence and classification
of dissection, final pre-dilated balloon diameter, DCB diameter, incidence of salvage stent
implantation, residual stenosis, operation time, and radiation dose were recorded
intraoperatively. The incidence of revascularization and angina pectoris during
hospitalization were recorded. Minimum lumen diameter and diameter stenosis rate were
detected by coronary angiography 9 months after discharge. MACE events were observed 12
months after discharge.
With residual lumens stenosis less than 30% as the criteria the pure balloon pre expansion of
coronary artery lesions in situ can result in up to 10-40% of the incidence of retrospective
stenting, limits the DCB in coronary artery lesions in situ treatment, the application of
quasi simple balloon expansion and pathological changes of RFR guiding ladder balloon
expansion of pretreatment in the DCB treatment of coronary artery lesions, the application of
in situ To verify that rFR-guided stepped-balloon dilation compared with balloon dilation
alone can increase the success rate of DCB in the treatment of orthotopic coronary artery
lesions, thus providing a new pre-dilation treatment method for DCB to be more effective and
safe in the application of orthotopic coronary artery lesions.
