Comparing two strategies for treating coronary bifurcation lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study aims to compare the effectiveness of a provisional 1-stent strategy using a drug-eluting balloon against a planned 2-stent strategy in patients with non-left main coronary true-bifurcation lesions. Participants will be randomly assigned to either treatment approach, with the goal of determining if the 1-stent strategy is non-inferior to the 2-stent strategy regarding target lesion failures. The study will assess outcomes such as cardiac death, target vessel myocardial infarction, and target vessel revascularization. Treatment decisions will be made at the discretion of the healthcare provider based on the patient's condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

① 19+ years old

② Patients with the following lesions and clinical factors. 2-1. The lesion factor: Visually confirmed diameter of the 2.25-2.75 mm in branched vessels, where the main blood vessel's diameter is at least 2.5 mm; the lesion at the branched vessels is of a Medina classification (1,1,1), (1,0,1), or (0,1,1), with a true bifurcation; a de novo lesion.

2-2 Clinical factors: Stable angina pectoris, unstable angina pectoris, or myocardial infarction with an elevated non-ST segment, all at least 24 hours after their last treatment.

③ Patients who understood the definitions of the test group and the control group and the risks involved in the treatment, and with voluntary, informed consent to participate in the study, as provided either by the patient or their legal representatives.

Exclusion Criteria:

* Patients with myocardial infarction involving an elevated ST segment, or patients with an LM coronary true-bifurcation lesion.

  * Patients who are ruled out by the treatment provider because the 2-stent strategy was deemed unsuitable to the patient due to a clinical condition.

    * A patient with aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel) contraindications.

      * A patient who experienced psychogenic shock at the time of admission, or showed severe left ventricle insufficiency (where the left ventricle ejection fraction is less than 30%.)

        * A patient who requires prolonged anti-coagulative treatment (warfarin or a new oral anti-coagulant \[NOAC\])

          * A patient who is currently hemorrhagic, or has a high risk of major hemorrhage (active peptic ulcer, GI lesions with high hemorrhagic risks, malicious tumors with a high risk of hemorrhage) ⑦ A patient with a history of intra-cerebral hemorrhage or intra-cerebral aneurysm.

            * A patient for whom surgery that requires antiplatelet treatment intervention is scheduled within the next six months.

              ⑨ A patient with severe hepatic diseases (abdominal effusion) Platelet count at less than 80,000 cells/mm3 Hgb count at less than 10 g/dL

              ⑩ A patient who appears to be at risk of bradycardia (a patient with an insufficiency of the said function, or a patient without a permanent pacemaker despite a grade 2 or higher atrioventricular block).

              ⑪ A patient who tested positive in a pregnancy test, or is currently breastfeeding

              ⑫ A patient with less than one year of remaining life expectancy due to comorbidity (based on the medical judgment of the investigator).

              ⑬ A patient who is already participating in another randomized clinical study for other medicines or medical devices, where the primary end point has not been reached.

              ⑭ A patient who did not sign her informed consent form, or could not be traced in the long-term.

Where it's running

• St. Vincent's Hospital , the Catholic University
  Suwon, Gyeonggi-do, South Korea Recruiting

Study contacts

• Principal investigator: Sung-Ho Her, MD. PhD. — St Vincent's Hospital
• Study coordinator: Sung-Ho Her, MD. PhD.
• Email: hhhsungho@naver.com
• Phone: +82312598397

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• QFR-guided virtual stenting to optimize PCI before the procedure

  We’re testing whether using QFR-based virtual stenting before PCI can improve heart-procedure outcomes compared with standard angiography planning in adults with coronary artery disease.

  Recruiting China National Center for Cardiovascular Diseases · Beijing, Beijing Municipality · NCT07635407

• LONG NAGOMI PMCF: follow-up of the Ultimaster Nagomi stent in long coronary artery lesions

  This project tests the Ultimaster Nagomi drug-eluting stent in adults undergoing PCI for long coronary lesions to collect real-world safety and effectiveness data.

  Recruiting at 10 sites Fundación EPIC · Cabueñes and 9 other locations · NCT07399002

• Coronary CT angiography versus standard follow-up after stent placement for high-risk patients

  This trial will test whether using coronary CT angiography instead of usual follow-up care helps people at high risk after stent placement stay healthier.

  Recruiting at 2 sites Samsung Medical Center · Bucheon-si and 21 other locations · NCT07009418

• Ultrathin strut stent for patients on blood thinners

  This study is testing a new type of stent for patients on blood thinners to see if it can safely reduce the time they need to take additional blood-thinning medication after heart procedures.

  Recruiting at 13 sites Fundación EPIC · Albacete and 12 other locations · NCT06863155

• Essential Pro paclitaxel‑eluting coronary balloon post-market follow-up (rEPIC04E-HK)

  This project will follow people with coronary artery disease treated with the Essential Pro paclitaxel‑eluting coronary balloon to see if the device is safe and works well in routine care.

  Recruiting Fundación EPIC · Lai Chi Kok · NCT06631157

• Investigating different doses of adenosine for heart imaging

  This study tests whether different doses of adenosine can improve heart imaging for people suspected of having chronic coronary syndrome.

  Recruiting Phase 4 Region Skane · Lund · NCT06578234

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.