Using a cutting balloon to treat calcified coronary lesions with stents
Assessment of Cutting-Balloon Angioplasty With Novel Bioabsorbable Polymer-Coated, Everolimus-Eluting Stent in the Treatment of Calcified Coronary Lesions Guided by Intravascular Ultrasound
NA · Soonchunhyang University Hospital · NCT06177808
This study tests whether using a cutting balloon can help doctors better treat hard, calcified heart arteries when placing stents, and it's for patients with coronary artery disease.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 19 Years to 90 Years |
| Sex | All |
| Sponsor | Soonchunhyang University Hospital (other) |
| Locations | 1 site (Bucheon, Gyeonggi-do) |
| Trial ID | NCT06177808 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a cutting balloon in modifying calcified coronary lesions to facilitate stent implantation, comparing it to a non-compliant balloon. It includes patients with varying degrees of calcification and aims to assess long-term clinical outcomes, procedural factors, and operator convenience. The study seeks to provide evidence that could broaden the use of cutting balloons and influence insurance coverage policies. By focusing on both safety and efficacy, it aims to improve treatment outcomes for patients with coronary artery disease.
Who should consider this trial
Good fit: Ideal candidates are individuals with coronary artery disease and calcified lesions suitable for percutaneous coronary intervention.
Not a fit: Patients with extremely tortuous lesions, those requiring rotational atherectomy, or those with acute STEMI may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better stent implantation outcomes and improved long-term health for patients with calcified coronary lesions.
How similar studies have performed: While previous studies have focused on severe calcifications, this study's approach is novel as it includes a broader range of calcification severity and emphasizes long-term outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Coronary artery disease including ISR or de novo lesion with a stenosis of ≥ 70% 2. Target lesion calcification (an arch of calcium at least 100 degrees) was confirmed by imaging studies 3. A reference vessel diameter between 2.0 and 4.0mm and deemed suitable for PCI Exclusion Criteria: 1. Extremely tortuous or angulated lesions 2. Lesions with dissection before balloon pre-dilatation 3. Lesions within the vein graft 4. Extremely narrow lesions which need to rotational atherectomy 5. STEMI 6. Comorbidities which preclude the achievement of one year follow up
Where this trial is running
Bucheon, Gyeonggi-do
- Soonchunhyang University Hospital — Bucheon, Gyeonggi-do, Korea, Republic of (RECRUITING)
Study contacts
- Study coordinator: Jon Suh, PhD
- Email: immanuel@schmc.ac.kr
- Phone: 082-10-3407-3843
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, Cutting balloon, Calcified coronary lesion, Calcium modification, Balloon angioplasty, Intravascular ultrasound