NCT04242134Active, not recruiting
Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions
Comparison of Noncompliant Balloon With Drug-coating Balloon Angioplasties for Side Branch After Provisional Stenting for Patients With True Coronary Bifurcation Lesions
Source: ClinicalTrials.gov · Last updated 15 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 784 (actual)
- First submitted
- 20 Jan 2020
- Start date
- 8 Sept 2020
- Primary completion date
- 27 Jun 2024
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical University
- Diseases
- Coronary artery disease
- NCT number
- NCT04242134
What you commit to
- Study type: Interventional
- Participants enrolled: 784
- From 8 Sept 2020 to the primary completion date, 27 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient has known allergy to the study balloon/stent system or protocol-required concomitant medications.
Other illness
- Patient has any other serious medical illness that may reduce life expectancy to less than 12 months.
Lab values
- Patient is intolerable to dual anti-platelet therapy.
Other
- Patient with STEMI (within 1-week from the onset of chest pain to admission).
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanjing First Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.