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

University National Heart Hospital

Status: Enrolling

Conditions: Coronary Artery Disease

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06197022

SCA-DEB_2022

Details and patient eligibility

About

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.

Enrollment: 106 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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106 participants in 1 patient group

Scoring Balloon Angioplasty

Other group

Description:

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.

Treatment:

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