de Novo Coronary LesionsREDUCENCT05107024
Resting Full-cycle Ratio-guided Step by Step Balloon Dilation
A study testing RFR-guided step by step balloon dilation and Traditional balloon dilation in people with de Novo Coronary Lesions, run by Shenzhen People's Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- de Novo Coronary Lesions
- What is being tested?
- RFR-guided step by step balloon dilation and Traditional balloon dilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Resting Full-cycle Ratio-guided Step by Step Dilation for Drug-coated Balloon Treatment of de Novo Coronary Lesions (REDUCE) Study
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.
Read the detailed 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.
- Conditions
- de Novo Coronary Lesions
- Being tested
- RFR-guided step by step balloon dilation, Traditional balloon dilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFR-guided step by step balloon dilationDevice
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.
Traditional balloon dilationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: RFR-guided step by step balloon dilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During sample collection (1 year)
Secondary outcomes (2)
Incidence of adverse cardiac events (MACE)
All-cause death, myocardial infarction, target vessel remodeling (TVR), and vascular thrombosis
Measured: 2 years
Incidence of late lumen loss
Analysis of the minimum lumen diameter after operation and the minimum lumen diameter of the same vascular segment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start1 Dec 2021 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for de Novo Coronary LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shaohong Dong, Study chair, Shenzhen People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107024
- Sponsor's protocol ID
- Shenzhen REDUCE
- Acronym
- REDUCE
- Status last verified
- Oct 2021
- First submitted
- 27 Oct 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resting Full-cycle Ratio-guided Step by Step Dilation for Drug-coated Balloon Treatment of de Novo Coronary Lesions (REDUCE) Study
- ClinicalTrials.gov ID
- NCT05107024
- Acronym / sponsor ID
- REDUCE / Shenzhen REDUCE
- Conditions
- de Novo Coronary Lesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 4 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional balloon dilation group | Active comparator | Device: Traditional balloon dilationThe 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 |
| RFR-guided step by step balloon dilation group | Experimental | Device: RFR-guided step by step balloon dilationBalloon 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RFR-guided step by step balloon dilationThe 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 | RFR-guided step by step balloon dilation group |
| Traditional balloon dilationThe 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 | Device | Traditional balloon dilation group |
Primary outcome
Success rate of DCB treatment
Time frame: During sample collection (1 year)
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
2 secondary outcomes
Incidence of adverse cardiac events (MACE)
Time frame: 2 years
Incidence of late lumen loss
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for de Novo Coronary Lesions
Not yet recruitingObservational study
iLITE, Clinical Performance of the Angiolite™ Drug-Eluting Stent
PCI Patients, de Novo Coronary Lesions
Recruiting
AGENT DCB STANCE: Safety and Effectiveness Study of AGENT Drug-Coated Balloon Compared to Standard of Care Percutaneous Coronary Intervention (PCI) Treatment for de Novo Coronary Lesions
Coronary Arterial Disease (CAD), de Novo Lesions in Native Coronary Arteries
Recruiting
First-in-Human Study Using the SiroMax™ Sirolimus-Coated Balloon Catheter as a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to Treat Subjects Who Have Coronary Artery Disease (CAD) Involving In-Stent Restenosis (ISR) or an Unstented Lesion in a Small Coronary Vessel (DNSV).
Coronary Artery Disease, Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
Not yet recruiting
A Prospective, Multicenter, Randomized Controlled Clinical Study on the Safety and Efficacy of Biolimus Drug-Coated Balloon (DCB) Versus Drug-Eluting Stent (DES) in the Treatment of De Novo Coronary Artery Lesions
Patients With de Novo Coronary Artery Lesions
Not yet recruitingObservational study
Coronary Artery Drug-Coated Balloon Dilatation Catheter Clinical Trial Protocol
In-Stent Restenosis or De Novo Coronary Artery Lesions
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaohong Dong study chair
Shenzhen People's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing RFR-guided step by step balloon dilation and Traditional balloon dilation in people with de Novo Coronary Lesions, run by Shenzhen People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Sun (+86-755-22943205, sunxinflying@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of DCB treatment (time frame: During sample collection (1 year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021; AzTrials last refreshed its copy on 1 Nov 2026.