Assessment of Cutting-Balloon Angioplasty With Novel Bioabsorbable Polymer-Coated, Everolimus-Eluting Stent in the Treatment of Calcified Coronary Lesions Guided by Intravascular Ultrasound

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The study seeks to address the clinical question of how effectively a novel cutting balloon (Wolverine™) can modify calcified lesions for stent implantation in comparison with a non-compliant (NC) balloon, particularly when used alongside a bioabsorbable polymer-coated everolimus-eluting coronary stent (Synergy™). Most previous researches on cutting balloons focused on only severe calcifications and had limitations such as small sample sizes with retrospective designs, emphasizing on short-term imaging outcomes. This study differs by including mild to severe calcifications and evaluating long-term clinical outcomes, intraprocedural factors, and operator convenience. It aims to provide evidence that could potentially expand the indications for cutting balloon use and inform insurance coverage policies. The objective of the study is to test the safety and efficacy of the cutting balloon in preparing calcified coronary lesions for stent insertion compared to conventional methods.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 90
Healthy Volunteers: f
View:

• Coronary artery disease including ISR or de novo lesion with a stenosis of ≥ 70%

• Target lesion calcification (an arch of calcium at least 100 degrees) was confirmed by imaging studies

• A reference vessel diameter between 2.0 and 4.0mm and deemed suitable for PCI

Locations
Other Locations
Republic of Korea
Soonchunhyang University Hospital
RECRUITING
Bucheon-si
Contact Information
Primary
Jon Suh, PhD
immanuel@schmc.ac.kr
082-10-3407-3843
Backup
Eunbin Park
popori114@naver.com
082-10-9180-7781
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 250
Treatments
Experimental: Wolverine cutting balloon group
Patients who received PCI with Wolverine cutting balloon to modify calcified coronary lesion
Active_comparator: NC(Non-compliant) balloon group
Patients who received PCI with Non-compliant balloon to modify calcified coronary lesion
Related Therapeutic Areas
Sponsors
Collaborators: The Catholic University of Korea, Boston Scientific Corporation, Eulji University, Hanil General Hospital, Korea
Leads: Soonchunhyang University Hospital

This content was sourced from clinicaltrials.gov