Using a cutting balloon before placing a special heart stent
Cutting Balloon Predilation Prior to Abluminus Sirolimus-eluting Stent Implantation
This study is testing whether using a cutting balloon before placing a special heart stent can help people with new coronary artery disease have better results than using a standard balloon.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Hospital Universitario La Fe Academic / other |
| Locations | 3 sites (Barcelona and 2 other locations) |
| Trial ID | NCT05801003 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of using a cutting balloon for pre-dilation before the implantation of an Abluminus Sirolimus-eluting stent in patients with de novo coronary artery disease. It is a prospective, multicenter, randomized controlled trial involving 96 patients who will be randomly assigned to either the cutting balloon pre-dilation group or a standard balloon pre-dilation group. The goal is to determine which pre-dilation strategy leads to better clinical outcomes after stent implantation. Stent optimization will be guided by intracoronary imaging findings.
Who should consider this trial
Good fit: Ideal candidates are patients with symptomatic coronary artery disease or evidence of ischemia due to one or more coronary artery stenoses greater than 50%.
Not a fit: Patients with conditions such as cardiogenic shock, ST-segment elevation myocardial infarction, or those undergoing specific types of PCI procedures will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the effectiveness of stent implantation and reduce complications for patients with coronary artery disease.
How similar studies have performed: While the use of cutting balloons in coronary interventions has been explored, this specific approach with Abluminus Sirolimus-eluting stents is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Symptomatic coronary artery disease or evidence of ischemia in the presence of one or more coronary artery stenoses \>50% in a native coronary artery. Exclusion Criteria: 1. Cardiogenic shock 2. Patients presenting with ST-segment elevation myocardial infarction 3. Patients undergoing chronic total occlusions PCI 4. Patients undergoing left main PCI 5. Patients undergoing venous bypass graft lesions PCI 6. Patients with in-stent restenosis 7. Inability to provide informed consent 8. Life expectancy \<1year due to non-cardiac disease 9. Currently participating in another trial before reaching first endpoint There will be no exclusion based on mode of co-morbidities, left ventricular function, number of diseased vessels and lesions, or number of target lesions.
Where this trial is running
Barcelona and 2 other locations
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (Not_yet_recruiting)
- Hospital Universitario y Politécnico La Fe — Valencia, Spain (Recruiting)
- Hospital General de Valencia — Valencia, Spain (Not_yet_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.