Comparing two strategies for treating coronary bifurcation lesions
Comparison of PROVISIONal 1-stent Strategy with Drug-Eluting Balloon Versus Planned 2-stent Strategy in Patients with Non-LM Coronary True-Bifurcation Lesions.
This study is testing whether using one stent with a special balloon is just as good as using two stents for treating certain heart blockages in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 750 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Saint Vincent's Hospital, Korea Academic / other |
| Locations | 1 site (Suwon, Gyeonggi-do) |
| Trial ID | NCT06002932 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 and older with specific coronary artery lesions and stable or unstable angina.
Not a fit: Patients with ST-segment elevation myocardial infarction or left main coronary true-bifurcation lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive treatment option for patients with coronary bifurcation lesions, potentially reducing complications and improving recovery times.
How similar studies have performed: Previous studies have explored similar strategies in coronary interventions, indicating potential for success, though this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Suwon, Gyeonggi-do
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.