Improving stent placement in heart procedures
Optimization of Percutaneous Coronary Intervention After Stent Implantation With Liberal Use of High-pressure Non-compliant Balloon Post-dilatation Versus Contemporary Practice
Cathreine BV · NCT06558474
This study is trying to see if using a special technique during stent placement can help people with heart problems avoid complications and improve their treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cathreine BV (other) |
| Locations | 1 site (Eindhoven, North Brabant) |
| Trial ID | NCT06558474 on ClinicalTrials.gov |
What this trial studies
This study focuses on optimizing the outcomes of percutaneous coronary interventions (PCI) by employing a liberal post-dilatation strategy during stent deployment. It utilizes data from the Netherlands Heart Registration, which collects comprehensive information on cardiac procedures, to analyze the effects of post-dilatation on stent expansion and its subsequent impact on preventing complications like stent thrombosis and restenosis. The study aims to clarify the role of post-dilatation in routine clinical practice, addressing a gap in existing evidence regarding its benefits. By evaluating a large dataset, the study seeks to provide insights into best practices for stent optimization.
Who should consider this trial
Good fit: Ideal candidates for this study are patients over 18 years old undergoing PCI for any indication.
Not a fit: Patients who have undergone multiple PCIs within the last 365 days will not benefit from this study as only their first procedure will be included.
Why it matters
Potential benefit: If successful, this approach could lead to improved long-term outcomes for patients undergoing PCI, reducing the risk of complications associated with stent placement.
How similar studies have performed: While there is limited evidence on the routine use of post-dilatation, similar studies have explored its effects, indicating a need for further investigation in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients \>18 years old who undergo PCI for any indication are included in the register of the Netherlands Heart Registration and therefore included in the final analysis of this project Exclusion Criteria: \- If a patient has multiple PCIs within 365 days, only the first procedure is included.
Where this trial is running
Eindhoven, North Brabant
- Catharina Hospital — Eindhoven, North Brabant, Netherlands (RECRUITING)
Study contacts
- Study coordinator: K Teeuwen, MD, PhD
- Email: koen.teeuwen@catharinaziekenhuis.nl
- Phone: + 31 040 239 9111
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.
Conditions: Coronary Artery Disease, percutaneous coronary intervention, coronary artery disease, stent optimization, post-dilatation