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

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease
• Interventions: Device: Mozec™ SEB Sirolimus Eluting Rx PTCA Balloon Dilatation Catheter

• Registration Number: NCT06197022
• Lead Sponsor: University National Heart Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Status Verified: 2023-12
• Study First Submitted: 2023-12-25
• Study First Submitted QC: 2024-01-08
• Last Update Submitted: 2024-01-08
• Study First Posted: 2024-01-09
• Last Update Posted: 2024-01-09
• Primary Completion: 2024-10
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 106

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Scoring Balloon Angioplasty	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.

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiovascular Events (MACE)	12 months	Composite of non-fatal MI, cardiovascular death, and target lesion revascularization

Secondary Outcome Measures

Name	Time	Method
Target Vessel Failure (TVF)	3 months, 6 months, 12 months, 24 months, 36 months	It is defined as the composite of cardiovascular death, target vessel myocardial infarction and target vessel revascularization
Cardiovascular Death	3 months, 6 months, 12 months, 24 months, 36 months	Defined as per Academic Research Consortium-2 (ARC-2) criteria
Target Lesion Revascularization (TLR)	3 months, 6 months, 12 months, 24 months, 36 months	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
Non-fatal Myocardial Infarction	3 months, 6 months, 12 months, 24 months, 36 months	Non-fatal myocardial infarction (MI) is defined as per the fourth universal definition of MI
Restenosis	3 months	Defined as \>50% stenosis at the treated segment.
Major bleeding	3 months, 6 months, 12 months, 2 years and 3 years	Defined as bleeding that causes hemodynamic instability and/or leads to blood transfusion
Quality of Life Score	Baseline, 3 months, 6 months, 12 months	OverallHealthStatusassessedbyShortFormSurvey(SF-12)
Device success	During the procedure	Defined as the ability of the study device to be delivered, dilated, and retrieved from the target lesion

Trial Locations

Locations (1)

Medica Core Heart Hopsital; 🇧🇬 Ruse, Bulgaria