Scoring-Balloon Angioplasty and Sirolimus-Eluting Balloon Angioplasty for the Treatment of Diffuse, Small Vessel Coronary Artery Disease (SCA-DEB Study)

Coronary Artery Disease Clinical Trial

— SCA-DEB  

Official title:

Scoring-Balloon Angioplasty and Sirolimus-Eluting Balloon Angioplasty for the Treatment of Diffuse, Small Vessel Coronary Artery Disease (SCA-DEB Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06197022
• Other study ID #: SCA-DEB_2022
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: University National Heart Hospital
• Contact: Dobrin Vassilev, MD, PhD
• Phone: +3590886846550
• Email: dobrinv[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

1. Patientsaged=18years.

2. 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.

Exclusion Criteria:

1. Life expectancy < 2 years

2. Left ventricular EF =40%

3. Pregnantorlactatingfemales.

4. Moderate and moderate-to-severe valvular heart disease.

5. Hemodynamic instability.

6. Severe renal dysfunction, defined as an eGFR <30 mL/min/1.73 m2

7. Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, bivalirudin, prasugrel, ticagrelor and drug such as Sirolimus (Rapamycin) or similar drugs or any analogue or derivative, hydrogenated castor oil, PVP or any contrast media.

8. Patients in whom anti-platelet and/or anti-coagulant therapy are contraindicated.

9. Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.

10. Transplant patients.

11. Patients with calcified lesion requiring other type of treatment such as Rotational Atherectomy.

12. Unprotected left main coronary artery lesions

13. Coronary artery spasm in the absence of a significant stenosis.

14. Patients whose diseased segment cannot be pre-dilated or prepared before drug coated balloon treatment.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Mozec™ SEB Sirolimus Eluting Rx PTCA Balloon Dilatation Catheter
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.

Locations

Country	Name	City	State
Bulgaria	Medica Core Heart Hopsital	Ruse

Sponsors (2)

Lead Sponsor	Collaborator
University National Heart Hospital	Meril Life Sciences Pvt. Ltd.

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiovascular Events (MACE)	Composite of non-fatal MI, cardiovascular death, and target lesion revascularization	12 months
Secondary	Cardiovascular Death	Defined as per Academic Research Consortium-2 (ARC-2) criteria	3 months, 6 months, 12 months, 24 months, 36 months
Secondary	Non-fatal Myocardial Infarction	Non-fatal myocardial infarction (MI) is defined as per the fourth universal definition of MI	3 months, 6 months, 12 months, 24 months, 36 months
Secondary	Target Lesion Revascularization (TLR)	It is defined as repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion	3 months, 6 months, 12 months, 24 months, 36 months
Secondary	Target Vessel Failure (TVF)	It is defined as the composite of cardiovascular death, target vessel myocardial infarction and target vessel revascularization	3 months, 6 months, 12 months, 24 months, 36 months
Secondary	Restenosis	Defined as >50% stenosis at the treated segment.	3 months
Secondary	Major bleeding	Defined as bleeding that causes hemodynamic instability and/or leads to blood transfusion	3 months, 6 months, 12 months, 2 years and 3 years
Secondary	Quality of Life Score	OverallHealthStatusassessedbyShortFormSurvey(SF-12)	Baseline, 3 months, 6 months, 12 months
Secondary	Device success	Defined as the ability of the study device to be delivered, dilated, and retrieved from the target lesion	During the procedure