Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions

NCT04242134 | Active Not Recruiting DMC

• 1 other identifier: NFH20191128
• Study Type: interventional
• Target: 784
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Rate of major adverse cardiac event

  MACE defined as the composite of cardiac death, myocardial infarction (MI), and clinically driven TLR.

  12 months after angioplasty

Secondary Outcomes (4)

• Rate of all-cause death or cardiac death

  12 months after angioplasty

• Rate of periprocedural MI, Spontaneous MI, or target vessel MI

  12 months after angioplasty

• Rate of clinically-driven TLR or TVR

  12 months after angioplasty

• Rate of thrombosis

  12 months after angioplasty

Other Outcomes (3)

• Rate of Angiographic success

  1 day

• Rate of clinical procedural success

  7 day

• Crossover rate

  1 day

Study Arms (2)

PS-DCB

EXPERIMENTAL

For PS-DCB group 1. NC balloon dilating ostial side branch (SB) (1:1 ratio). 2. DCB dilating SB. Specifically, the DCB, which had to be 2-3 mm longer on each side than the predilatation balloon, was inflated at nominal pressure for 30\~ 60 s. The ratio of the DCB diameter to the nominal diameter of the SB was recommended to be between 0.8 and 1.0. DCB should be delivered to the lesion within 2 min after entering human body. 3. Kissing inflation using 2 noncomplian balloons. 4. Stenting side branch with T and protrusion (TAP) technique if any of the following issues was observed after kissing balloon inflation: \>type C dissection or thrombolysis in myocardial infarction (TIMI) flow \<3. 5. Final kissing inflation and proximal optimal technique (POT).

Device: Drug-coating balloon

PS-NCB

ACTIVE COMPARATOR

For PS-NCB group 1. NC balloon dilating ostial SB (1:1 ratio). 2. Kissing inflation using 2 NC balloons. 3. Stenting side branch with TAP technique if any of the following issues was observed after kissing balloon inflation: \>type C dissection or thrombolysis in myocardial infarction (TIMI) flow \<3. 4. Final kissing inflation and proximal optimal technique (POT).

Device: Drug-coating balloon

Interventions

Drug-coating balloon DEVICE

Provisional stenting technique with DCB

Also known as: DCB

PS-DCB; PS-NCB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be age ≥18 years.
• Subject has silent ischemia, or stable/unstable angina, or acute MI older than 1-week from the onset of chest pain to admission.
• 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.
• Subject is willing to comply with all protocol-required follow-up evaluations.
• 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).
• Target lesion reference vessel diameter (both main vessel and side branch) ≥ 2.5 mm by visual estimation.
• Target lesion must have visually estimated stenosis ≥50%.
• Target lesion length of side branch must be \<10 mm by visual estimation.
• Ostium side branch must have visually estimated stenosis ≥70% after stenting of the main vessel.

You may not qualify if:

• Patient with STEMI (within 1-week from the onset of chest pain to admission).
• Patient has known allergy to the study balloon/stent system or protocol-required concomitant medications.
• Patient is intolerable to dual anti-platelet therapy.
• Patient has any other serious medical illness that may reduce life expectancy to less than 12 months.
• Patient is pregnant or nursing.
• Patient is participating in another clinical trial that has not reached its primary endpoint within 24 months after the index procedure.
• Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation.
• Restenotic lesion.
• Chronic total occlusion (CTO) lesion in either main vessel or side branch is not successfully recanalized.
• Severe calcification needing rotational atherectomy.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

Related Publications (1)

• 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.

  PMID: 35277400 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Shao-Liang Chen, MD, PhD

  Nanjing First Hospital, Nanjing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will remain blinded until the final study results are released.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Model Details: 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.

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: January 27, 2020
• Study Start: September 8, 2020
• Primary Completion: June 27, 2024
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)