Scoring-Balloon Angioplasty and Sirolimus-Eluting Balloon Angioplasty for the Treatment of Diffuse, Small Vessel Coronary Artery Disease (SCA-DEB Study)
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This is a prospective, single-center, single-arm study to evaluate the feasibility and safety of the combination of Scoring-Balloon Angioplasty and Sirolimus-Eluting Balloon Angioplasty for the treatment of diffuse, small vessel coronary artery disease. The objective of the study is to demonstrate the feasibility and safety of the combination of scoring-balloon angioplasty (SBA) plus sirolimus-eluting balloon angioplasty (SEBA) for diffuse (lesion length ≥20 mm), small vessel (diameter 1.5 mm -2.75 mm) coronary disease.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 95
Healthy Volunteers: f
View:
• Patientsaged≥18years.
• Presence of epicardial coronary artery disease with lesion length ≥ 20 mm and vessel diameter less than 2.75 mm and more than 1.5 mm with diameter stenosis \>50% by visual evaluation.
Locations
Other Locations
Bulgaria
Medica Core Heart Hopsital
RECRUITING
Rousse
Contact Information
Primary
Dobrin Vassilev, MD, PhD
dobrinv@gmail.com
+3590886846550
Time Frame
Start Date: 2022-10-01
Estimated Completion Date: 2024-12
Participants
Target number of participants: 106
Treatments
Other: Scoring Balloon Angioplasty
Combination of scoring-balloon angioplasty (SBA) plus sirolimus-eluting balloon angioplasty (SEBA) for diffuse (lesion length ≥20 mm), small vessel (diameter 1.5 mm -2.75 mm) coronary disease.
Related Therapeutic Areas
Sponsors
Leads: University National Heart Hospital
Collaborators: Meril Life Sciences Pvt. Ltd.