Coronary Artery DiseasePREPARE-NSENCT03817801
Comparison of Scoring Balloon and Conventional Balloon Predilation Before Drug Coated Balloon for de Novo Lesion in Patients With High Bleeding Risk
A study testing NSE balloon and NC balloon in people with Coronary Artery Disease, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
This study is designed to investigate whether scoring balloon (non-slip element, NSE) predilation compared to non-compliant (NC) balloon predilation for de novo lesion in patients with high bleeding risk and planning to receive drug-coated balloon (DCB) treatment will lead to lower change in minimal lumen area (MLA)… Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- NSE balloon and NC balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2019to 30 Dec 2021
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- De Novo lesion, suitable for intravascular ultrasound (IVUS) and fractional flow reserve (FFR) test;
- Coronary artery disease (CAD) patients with high risk of bleeding
Who cannot join
- Previous coronary artery bypass graft (CABG) patients
- Stent implantation in the target vessel
- Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2
- Acute ST segment elevation myocardial infarction (STEMI) within 48 hours
- Contraindications to contrast media, antiplatelet therapy, or paclitaxel
- Cardiac shock
- Pregnancy
- Expected life less than 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Scoring Balloon and Conventional Balloon Predilation Before Drug Coated Balloon for de Novo Lesion in Patients With High Bleeding Risk: A Randomized, Single-center, Pilot Study
This study is designed to investigate whether scoring balloon (non-slip element, NSE) predilation compared to non-compliant (NC) balloon predilation for de novo lesion in patients with high bleeding risk and planning to receive drug-coated balloon (DCB) treatment will lead to lower change in minimal lumen area (MLA) at 6 months by intravascular ultrasound (IVUS).
Read the detailed description
This is a pilot study that aim to enroll 60 subjects with high bleeding risk.
All patients with coronary artery stenosis suitable for DCB treatment will undergo 1:1 randomization either to NSE predilation or NC balloon predilation using a randomization schedule.
All subjects will be screened according to the predefined inclusion and exclusion criteria per protocol and will further undergo IVUS before DCB treatment. Data and images will be collected during the index procedure, and at the predefined 6-month IVUS follow-up visit.
- Conditions
- Coronary Artery Disease
- Being tested
- NSE balloon, NC balloon
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSE balloonDevice
NSE (Goodman®) predilation + DCB (Sequent® Please) treatment
NC balloonDevice
NC balloon predilation + DCB (Sequent® Please) treatment
| Study group | Role | What they receive |
|---|---|---|
| non-slip element (NSE) predilation | Experimental | In the NSE predilation group, NSE predilation will be performed for all lesions preparation before drug-coated balloon (DCB) treatment. Receives: Device: NSE balloon |
| non-compliant (NC) balloon predilation | Active comparator | In the NC balloon predilation group, NC balloon predilation will be performed for all lesions preparation before DCB treatment. Receives: Device: NC balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
The absolute change in minimal lumen area (MLA)
The absolute change in MLA from post-procedure to 6-month follow-up identified by intravascular ultrasound (IVUS)
Measured: 6 months
Secondary outcomes (11)
Bailout drug-eluting stents (DES) implantation rate
Bailout DES implantation rate during procedure by angiographic criteria
Measured: During procedure
Fractional Flow Reserve (FFR) value
FFR value after balloon predilation measured by FFR
Measured: immediately after balloon predilation
Minimum lumen area (MLA)
MLA after procedure by IVUS
Measured: immediately after procedure
Minimum lumen diameter (MLD)
MLD after procedure by IVUS
Measured: immediately after procedure
Plaque burden
Plaque burden after procedure by IVUS
Measured: immediately after procedure
Dissection
Dissection after procedure by IVUS
Measured: immediately after procedure
Atheroma volume
Atheroma volume after procedure by IVUS
Measured: immediately after procedure
The diameter stenosis of target lesion
The diameter stenosis of target lesion from post-procedure to 6-month follow-up by angiography
Measured: 6 months
The late lumen loss of target lesion
The late lumen loss of target lesion from post-procedure to 6-month follow-up by angiography
Measured: 6 months
The binary restenosis of target lesion
The binary restenosis of target lesion from post-procedure to 6-month follow-up by angiography
Measured: 6 months
The composite of cardiac death, myocardial infarction, target lesion revascularization (TLR), and target lesion thrombosis
The composite of cardiac death, myocardial infarction, TLR, and target lesion thrombosis at 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start30 Jul 2019
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- Model description
- Patients will undergo 1:1 randomization to either non-slip element (NSE) predilation which will be the treatment group or non-compliant (NC) balloon predilation which will be the control group. The initiation of the trial is defined as the time of randomization. After study subjects' enrollment and randomization, the study intervention will take place immediately. The follow-up visits for the primary endpoint are scheduled at 1and 6 months after the index procedure.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junjie Zhang, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Shao-Liang Chen, MD, PhD, Study chair, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817801
- Sponsor's protocol ID
- NFH20190104
- Acronym
- PREPARE-NSE
- Status last verified
- Apr 2022
- First submitted
- 21 Jan 2019
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Scoring Balloon and Conventional Balloon Predilation Before Drug Coated Balloon for de Novo Lesion in Patients With High Bleeding Risk: A Randomized, Single-center, Pilot Study
- ClinicalTrials.gov ID
- NCT03817801
- Acronym / sponsor ID
- PREPARE-NSE / NFH20190104
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 28 Jan 2019 (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.
This study is designed to investigate whether scoring balloon (non-slip element, NSE) predilation compared to non-compliant (NC) balloon predilation for de novo lesion in patients with high bleeding risk and planning to receive drug-coated balloon (DCB) treatment will lead to lower change in minimal lumen area (MLA) at 6 months by intravascular ultrasound (IVUS).
Detailed description
This is a pilot study that aim to enroll 60 subjects with high bleeding risk.
All patients with coronary artery stenosis suitable for DCB treatment will undergo 1:1 randomization either to NSE predilation or NC balloon predilation using a randomization schedule.
All subjects will be screened according to the predefined inclusion and exclusion criteria per protocol and will further undergo IVUS before DCB treatment. Data and images will be collected during the index procedure, and at the predefined 6-month IVUS follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will undergo 1:1 randomization to either non-slip element (NSE) predilation which will be the treatment group or non-compliant (NC) balloon predilation which will be the control group. The initiation of the trial is defined as the time of randomization. After study subjects' enrollment and randomization, the study intervention will take place immediately. The follow-up visits for the primary endpoint are scheduled at 1and 6 months after the index procedure.
| Arm | Type | Receives |
|---|---|---|
| non-slip element (NSE) predilation | Experimental | Device: NSE balloonIn the NSE predilation group, NSE predilation will be performed for all lesions preparation before drug-coated balloon (DCB) treatment. |
| non-compliant (NC) balloon predilation | Active comparator | Device: NC balloonIn the NC balloon predilation group, NC balloon predilation will be performed for all lesions preparation before DCB treatment. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- De Novo lesion, suitable for intravascular ultrasound (IVUS) and fractional flow reserve (FFR) test;
- Coronary artery disease (CAD) patients with high risk of bleeding
Key exclusion criteria (8 listed)
- Previous coronary artery bypass graft (CABG) patients
- Stent implantation in the target vessel
- Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2
- Acute ST segment elevation myocardial infarction (STEMI) within 48 hours
- Contraindications to contrast media, antiplatelet therapy, or paclitaxel
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 |
|---|---|---|
| NSE balloonNSE (Goodman®) predilation + DCB (Sequent® Please) treatment | Device | non-slip element (NSE) predilation |
| NC balloonNC balloon predilation + DCB (Sequent® Please) treatment | Device | non-compliant (NC) balloon predilation |
Primary outcome
The absolute change in minimal lumen area (MLA)
Time frame: 6 months
The absolute change in MLA from post-procedure to 6-month follow-up identified by intravascular ultrasound (IVUS)
11 secondary outcomes
Bailout drug-eluting stents (DES) implantation rate
Time frame: During procedure
Fractional Flow Reserve (FFR) value
Time frame: immediately after balloon predilation
Minimum lumen area (MLA)
Time frame: immediately after procedure
Minimum lumen diameter (MLD)
Time frame: immediately after procedure
Plaque burden
Time frame: immediately after procedure
Dissection
Time frame: immediately after procedure
Atheroma volume
Time frame: immediately after procedure
The diameter stenosis of target lesion
Time frame: 6 months
The late lumen loss of target lesion
Time frame: 6 months
The binary restenosis of target lesion
Time frame: 6 months
The composite of cardiac death, myocardial infarction, target lesion revascularization (TLR), and target lesion thrombosis
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Shao-Liang Chen, MD, PhD study chair
Nanjing First Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NSE balloon and NC balloon in people with Coronary Artery Disease, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The absolute change in minimal lumen area (MLA) (time frame: 6 months). 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 26 Apr 2022.