Comparing PCI strategies for elderly patients with complex coronary artery calcifications
A Cohort Study of PCI Strategies for Severely Calcified Lesions of Complex Coronary Arteries in the Elderly
This study is testing whether standard stenting or a combination of stenting with a special balloon can help older patients with hard-to-treat heart artery blockages have better heart health over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2100 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Henan Institute of Cardiovascular Epidemiology Academic / other |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT06168422 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the prognostic outcomes of different percutaneous coronary intervention (PCI) strategies in elderly patients suffering from complex calcified lesions in their coronary arteries. Participants aged 60 and older will be divided into two groups, receiving either standard stenting or a combination of stenting with pharmacologic balloon implantation. The study will monitor these patients for one year to assess the occurrence of major adverse cardiovascular events, providing insights into the effectiveness of these approaches in this specific population.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 60 and above 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 with severe comorbid conditions affecting their cardiovascular stability.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for elderly patients with complex coronary artery disease, potentially reducing adverse cardiovascular events.
How similar studies have performed: While there have been studies on PCI strategies, this specific approach focusing on elderly patients with severely calcified lesions is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 60 years; 2. Meet the indications for coronary intervention; 3. IVUS examination suggests severe calcified lesions (calcification angle \>270°) or OCT examination suggests severe calcified lesions (calcification angle \>180° and/or length \>5mm and/or thickness \>0.5mm); 4. The diameter of the target lesion vessel is greater than 2.75mm; 5. The total length of the lesion is more than 60mm and/or the number of lesions to be treated is ≥3 and/or the number of vessels to be treated is ≥2. Exclusion Criteria: 1. inability to provide written informed consent; 2. inability to administer antiplatelet agents and anticoagulant therapy; 3. the subject is participating in other unfinished clinical trials; 4. life expectancy \<1 year; 5. non-in situ vascular lesions; 6. patients with haemodynamic instability; 7. Previous stroke within 6 months. 8. left main stem lesions.
Where this trial is running
Zhengzhou, Henan
- Fuwai Central China Cardiovascular Hospital — Zhengzhou, Henan, China (Recruiting)
Study contacts
- Principal investigator: Muwei Li — Fuwai central China cardiovascular hospotial
- Study coordinator: Quan Guo
- 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.