Comparing drug balloons and drug-coated stents for elderly patients with severe calcified coronary lesions
Comparison of Drug-coated Balloon and Drug-eluting Stent for Severe Calcification of de Novo Lesion in Elderly Coronary Heart Disease
This study is testing whether drug-coated balloons are just as effective as drug-coated stents for treating severe heart artery blockages in older patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Henan Institute of Cardiovascular Epidemiology Academic / other |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT05750771 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of drug-coated balloons (DCB) versus drug-eluting stents (DES) in treating severe calcified lesions in elderly patients with coronary artery disease. The study focuses on determining whether DCB is non-inferior to DES for large vessel calcified lesions in this demographic. Additionally, it seeks to develop a method for accurately identifying the nature and extent of calcified lesions to guide treatment decisions. The trial will involve patients over 60 years of age who meet specific criteria related to lesion severity and vessel diameter.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients over 60 years old with severe calcified coronary lesions requiring intervention.
Not a fit: Patients who may not benefit from this study include those with life expectancy less than one year or those unable to undergo necessary medical procedures.
Why it matters
Potential benefit: If successful, this study could provide a less invasive treatment option for elderly patients with severe coronary artery disease.
How similar studies have performed: Other studies have explored similar interventions, but this specific comparison of DCB and DES in elderly patients with severe calcification is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1. older than 60 years of age. * 2. meeting the indications for coronary intervention. * 3. IVUS examination suggests severe calcified lesions (calcification angle \> 270° at the target lesion) or OCT examination suggests severe calcified lesions (calcification angle \> 180° and/or length \> 5 mm and/or thickness \> 0.5 mm); * 4. Target lesion vessel diameter \> 2.5 mm Exclusion Criteria: * 1. inability to provide written informed consent. * 2. unable to administer antiplatelet agents and anticoagulant therapy; have allergies to heparin, contrast agents, etc. * 3. the subject is participating in another uncompleted clinical trial * 4. life expectancy \<1 year. * 5. non-in situ vascular lesions. * 6. cardiogenic shock. * 7. Patients with hemodynamic instability
Where this trial is running
Zhengzhou, Henan
- Fuwai central China cardiovascular Hospital — Zhengzhou, Henan, China (Recruiting)
Study contacts
- Study coordinator: Quan Guo, MD
- Email: xinyiguoquan@163.com
- Phone: +8615670510031
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.