Clinical trial NCT04242134: Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions
Official title: Comparison of Noncompliant Balloon With Drug-coating Balloon Angioplasties for Side Branch After Provisional Stenting for Patients With True Coronary Bifurcation Lesions
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 784
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of major adverse cardiac event
timeFrame: 12 months after angioplasty
Secondary outcomes:
measure: Rate of all-cause death or cardiac death
timeFrame: 12 months after angioplasty
measure: Rate of periprocedural MI, Spontaneous MI, or target vessel MI
timeFrame: 12 months after angioplasty
measure: Rate of clinically-driven TLR or TVR
timeFrame: 12 months after angioplasty
measure: Rate of thrombosis
timeFrame: 12 months after angioplasty
Other outcomes:
measure: Rate of Angiographic success
timeFrame: 1 day
measure: Rate of clinical procedural success
timeFrame: 7 day
measure: Crossover rate
timeFrame: 1 day
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Shao-Liang Chen, MD, PhD
role: STUDY_CHAIR
References:
citation: Gao XF, Ge Z, Kan J, Kong XQ, Wang Y, Qiu CG, Tresukosol D, He YQ, Wu Q, Li JF, Yuan HT, Shen C, Chen X, Munawar M, Hanif B, Santoso T, Shin ES, Sheiban I, Ye F, Zhang JJ, Chen SL; DCB-BIF investigators. Rationale and design for comparison of non-compliant balloon with drug-coating balloon angioplasty for side branch after provisional stenting for patients with true coronary bifurcation lesions: a prospective, multicentre and randomised DCB-BIF trial. BMJ Open. 2022 Mar 11;12(3):e052788. doi: 10.1136/bmjopen-2021-052788.