Coronary Artery Disease
Conditions
Brief summary
This study is designed to investigate whether drug-coated balloon (DCB) compared to conventional balloon angioplasty for side branch after provisional stenting will lead to lower rates of the composite endpoint of major adverse cardiac event (MACE) at 12 months. The individual components of MACE include cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR). True bifurcation lesions were defined according to Medina classification.
Detailed description
This is a prospective, multi-center, randomized-controlled, single blind, superiority trial that will include 25 international sites. The investigators aim to enroll 784 subjects with true coronary bifurcation lesions in native coronary arterial segments. All patients with true coronary bifurcation lesions suitable for angioplasty will undergo 1:1 randomization either to PS (provisional stenting)-DCB or PS-NCB (noncompliant balloon) group using a randomization schedule blocked by site. All subjects will be screened according to the predefined inclusion and exclusion criteria per protocol and will further undergo angiography after successful stenting of the main vessel with ostium side branch visually estimated stenosis ≥70%. Data and images will be collected during the index procedure, during re-intervention in the case of clinically driven revascularization, and at the predefined 12-month clinical follow-up visit. All subjects will also undergo angiographic follow-up at 13 months.
Interventions
DEVICEDrug-coating balloon
Provisional stenting technique with DCB
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 PS-DCB which will be the treatment group or PS-NCB which will be the control group based on an online Clinical Research Data Management Platform provided by King Yee, Beijing CN. 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 1, 6, and 12 months after the index procedure. Angiographic follow-up is scheduled at 13 months.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject must be age ≥18 years. 2. Subject has silent ischemia, or stable/unstable angina, or acute MI older than 1-week from the onset of chest pain to admission. 3. Subject (or legal guardian) understands the trial design and treatment procedures and provides written informal consent before any trial-specific tests or procedures are performed. 4. Subject is willing to comply with all protocol-required follow-up evaluations. 5. Target lesion must be a true bifurcation lesion on coronary angiography (defined as Medina 0,1,1, Medina 1,0,1, or Medina 1,1,1 coronary bifurcation lesions) and is eligible for percutaneous coronary intervention (PCI). 6. Target lesion reference vessel diameter (both main vessel and side branch) ≥ 2.5 mm by visual estimation. 7. Target lesion must have visually estimated stenosis ≥50%. 8. Target lesion length of side branch must be \<10 mm by visual estimation. 9. Ostium side branch must have visually estimated stenosis ≥70% after stenting of the main vessel.
Exclusion criteria
1. Patient with STEMI (within 1-week from the onset of chest pain to admission). 2. Patient has known allergy to the study balloon/stent system or protocol-required concomitant medications. 3. Patient is intolerable to dual anti-platelet therapy. 4. Patient has any other serious medical illness that may reduce life expectancy to less than 12 months. 5. Patient is pregnant or nursing. 6. Patient is participating in another clinical trial that has not reached its primary endpoint within 24 months after the index procedure. 7. Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation. 8. Restenotic lesion. 9. Chronic total occlusion (CTO) lesion in either main vessel or side branch is not successfully recanalized. 10. Severe calcification needing rotational atherectomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of major adverse cardiac event | 12 months after angioplasty | MACE defined as the composite of cardiac death, myocardial infarction (MI), and clinically driven TLR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of periprocedural MI, Spontaneous MI, or target vessel MI | 12 months after angioplasty | According to the DCB-BIF trial definition. |
| Rate of all-cause death or cardiac death | 12 months after angioplasty | In general, all deaths are considered cardiac unless an alternate cause is unequivocally established, even among subjects with serious noncardiac comorbidities. |
| Rate of clinically-driven TLR or TVR | 12 months after angioplasty | Clinically driven revascularization includes repeat PCI or coronary artery bypass graft (CABG) for recurrent or persistent symptomatic ischemia and can be defined according to the relationship to the index PCI (target lesion). |
| Rate of thrombosis | 12 months after angioplasty | The safety endpoint was stent thrombosis (ST), according to the definition by Academic Research Consortium. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Crossover rate | 1 day | From single stent technique to two-stent technique |
| Rate of clinical procedural success | 7 day | Successful PCI without MACE during hospital stay. |
| Rate of Angiographic success | 1 day | PCI is considered successful for lesions treated with stent implantation if the residual diameter stenosis based on visual estimation is less than or equal to 10% and the final TIMI flow grade is 3. PCI is considered successful for lesions treated without stent implantation if the residual diameter stenosis based on visual estimation is less than or equal to 20% and the final TIMI flow grade is 3. |
Countries
China
Outcome results
None listed