Comparing drug coated balloons and drug eluting stents for heart artery treatment
Outcomes of Drug Coated Balloon Angioplasty, A UK Real Life Experience
This study is trying to see if using drug-coated balloons is better than drug-eluting stents for treating heart artery disease in patients with chest pain or heart attacks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Norfolk and Norwich University Hospitals NHS Foundation Trust Academic / other |
| Locations | 1 site (Norwich, Norfolk) |
| Trial ID | NCT04482972 on ClinicalTrials.gov |
What this trial studies
This study compares the outcomes of patients with coronary artery disease treated with drug coated balloons (DCB) versus those treated with drug eluting stents (DES). DCB is a newer technology that allows for treatment without the permanent implantation of a stent, which is typically used in such cases. The study will analyze a large clinical database from patients treated at the Norfolk and Norwich University Hospitals over the past decade, focusing on those presenting with myocardial infarction or stable angina. The aim is to gather comprehensive data on patient outcomes for both treatment methods.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with coronary artery disease who are being treated with either drug coated balloons or drug eluting stents.
Not a fit: Patients with coronary artery disease who are not candidates for either drug coated balloons or drug eluting stents may not receive benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of drug coated balloons, potentially leading to improved treatment options for patients with coronary artery disease.
How similar studies have performed: While there is limited data on DCB for de novo coronary artery disease, previous studies have shown promise for DCB in treating in-stent restenosis, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Patients with coronary artery disease being treated with DCB or DES
Where this trial is running
Norwich, Norfolk
- Norfolk and Norwich University Hospitals NHS Foundation Trust — Norwich, Norfolk, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Simon C Eccleshall — Norfolk and Norwich University Hospitals NHS Foundation Trust
- Study coordinator: Simon C Eccleshall, MRCP, MD
- Email: Simon.eccleshall@nnuh.nhs.uk
- Phone: 00441603286286
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.