Treatment for blocked coronary arteries using imaging technology
Drug-coated Balloons Treatment in Chronic Total Occlusion Coronary Artery Disease Guided by Intravascular Ultrasound
This study is testing if using special imaging technology can help doctors choose the best treatment for patients with completely blocked coronary arteries to improve their heart procedure outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Xuzhou Central Hospital Academic / other |
| Locations | 1 site (Xuzhou, Jiangsu) |
| Trial ID | NCT06050096 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of drug-coated balloon (DCB) therapy guided by intravascular ultrasound (IVUS) in patients with chronic total occlusion (CTO) of coronary arteries. The study aims to improve the success rate of percutaneous coronary intervention (PCI) by utilizing IVUS to assess vascular lumen and select appropriate treatment methods. Participants will undergo PCI with DCB treatment, and their outcomes will be monitored for at least 12 months. The study focuses on patients who have confirmed CTO and are seeking interventional treatment for coronary artery disease.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with diagnosed coronary artery disease and confirmed CTO seeking interventional treatment.
Not a fit: Patients with severe contrast allergies, known allergies to drug balloon coatings, or those with life-threatening conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved outcomes and reduced re-occlusion rates for patients with chronic total occlusion of coronary arteries.
How similar studies have performed: Other studies have shown promising results with IVUS-guided interventions, suggesting that this approach may enhance treatment efficacy for similar conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Over the age of 18, male or female; 2. Patients who meet the diagnostic criteria for coronary heart disease, have clinical symptoms and seek interventional treatment; 3. Coronary angiography confirmed that the blood vessels met the diagnostic criteria of CTO; 4. Sign informed consent and be willing to undergo follow-up for at least 12 months. Exclusion Criteria: 1. Patients with severe contrast allergy who cannot tolerate coronary angiography; 2. Patients known allergy to drug balloon coating; 3. Patients who is pregnant or breastfeeding; 4. Bleeding or other diseases, such as digestive tract ulcers, blood system diseases, etc., limit the use of platelet aggregation inhibitors and anticoagulation therapy; 5. Patients with cardiac shock; 6. Patients with a life expectancy of less than 1 year; 7. Other situations deemed unsuitable for inclusion by the researcher.
Where this trial is running
Xuzhou, Jiangsu
- Xuzhou Central Hospital — Xuzhou, Jiangsu, China (Recruiting)
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.