Combination of Scoring-Balloon and Sirolimus-Eluting Balloon Angioplasty for Small Vessel Coronary Artery Disease

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

This study is testing if using two types of balloon treatments together can safely help people with small, long blockages in their heart arteries.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 106 (estimated)
• Ages: 18 Years to 95 Years
• Sex: All
• Sponsor: University National Heart Hospital (Academic / other)
• Locations: 1 site (Ruse)
• Trial ID: NCT06197022 on ClinicalTrials.gov

What this trial studies

This study evaluates the feasibility and safety of using a combination of scoring-balloon angioplasty and sirolimus-eluting balloon angioplasty to treat diffuse, small vessel coronary artery disease. It focuses on patients with lesions that are at least 20 mm long and have a vessel diameter between 1.5 mm and 2.75 mm. The study is conducted at a single center and aims to demonstrate that this combined approach is both safe and effective for the targeted patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with specific coronary artery lesions that meet the study criteria.

Not a fit: Patients with severe comorbidities, such as significant heart dysfunction or those who cannot tolerate anti-platelet therapy, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new effective treatment option for patients with diffuse, small vessel coronary artery disease.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in treating coronary artery disease, suggesting potential for success.

Eligibility criteria

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.

Where this trial is running

Ruse

• Medica Core Heart Hopsital — Ruse, Bulgaria (Recruiting)

Study contacts

• Study coordinator: Dobrin Vassilev, MD, PhD

Conditions Coronary Artery Disease