Coronary Artery Disease
Conditions
Brief 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) 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.
Interventions
DEVICENSE balloon
NSE (Goodman®) predilation + DCB (Sequent® Please) treatment
DEVICENC balloon
NC balloon predilation + DCB (Sequent® Please) treatment
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessor will remain blinded until the final study results are released.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No
Inclusion criteria
* De Novo lesion, suitable for intravascular ultrasound (IVUS) and fractional flow reserve (FFR) test; * Coronary artery disease (CAD) patients with high risk of bleeding
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The absolute change in minimal lumen area (MLA) | 6 months | The absolute change in MLA from post-procedure to 6-month follow-up identified by intravascular ultrasound (IVUS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The diameter stenosis of target lesion | 6 months | The diameter stenosis of target lesion from post-procedure to 6-month follow-up by angiography |
| Bailout drug-eluting stents (DES) implantation rate | During procedure | Bailout DES implantation rate during procedure by angiographic criteria |
| Fractional Flow Reserve (FFR) value | immediately after balloon predilation | FFR value after balloon predilation measured by FFR |
| Minimum lumen area (MLA) | immediately after procedure | MLA after procedure by IVUS |
| Minimum lumen diameter (MLD) | immediately after procedure | MLD after procedure by IVUS |
| The late lumen loss of target lesion | 6 months | The late lumen loss of target lesion from post-procedure to 6-month follow-up by angiography |
| Dissection | immediately after procedure | Dissection after procedure by IVUS |
| Atheroma volume | immediately after procedure | Atheroma volume after procedure by IVUS |
| The binary restenosis of target lesion | 6 months | The binary restenosis of target lesion from post-procedure to 6-month follow-up by angiography |
| The composite of cardiac death, myocardial infarction, target lesion revascularization (TLR), and target lesion thrombosis | 6 months | The composite of cardiac death, myocardial infarction, TLR, and target lesion thrombosis at 6 months. |
| Plaque burden | immediately after procedure | Plaque burden after procedure by IVUS |
Countries
China
Outcome results
None listed