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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Mozec™ SEB Sirolimus Eluting Rx PTCA Balloon Dilatation Catheter

• Study Type: Interventional
• Enrollment (Estimated): 106
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dobrin Vassilev, MD, PhD; Phone Number: +3590886846550; Email: dobrinv@gmail.com

Study Locations

• Bulgaria
  • Ruse, Bulgaria, 7000
    • Recruiting
    • Medica Core Heart Hopsital
    • Contact: Dobrin Vassilev, MD, PhD; Phone Number: 00359886846550; Email: dobrinv@mail.comg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiovascular Events (MACE)	Composite of non-fatal MI, cardiovascular death, and target lesion revascularization	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular Death	Defined as per Academic Research Consortium-2 (ARC-2) criteria	3 months, 6 months, 12 months, 24 months, 36 months
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
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
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
Restenosis	Defined as >50% stenosis at the treated segment.	3 months
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
Quality of Life Score	OverallHealthStatusassessedbyShortFormSurvey(SF-12)	Baseline, 3 months, 6 months, 12 months
Device success	Defined as the ability of the study device to be delivered, dilated, and retrieved from the target lesion	During the procedure

Collaborators and Investigators

• Sponsor: University National Heart Hospital
• Collaborators: Meril Life Sciences Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 25, 2023
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: SCA-DEB_2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No