Clinical trial NCT06197022: Scoring-Balloon Angioplasty and Sirolimus-Eluting Balloon Angioplasty for the Treatment of Diffuse, Small Vessel Coronary Artery Disease (SCA-DEB Study)
Official title: Scoring-Balloon Angioplasty and Sirolimus-Eluting Balloon Angioplasty for the Treatment of Diffuse, Small Vessel Coronary Artery Disease (SCA-DEB Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: University National Heart Hospital
Sponsor class: OTHER
Collaborators: name: Meril Life Sciences Pvt. Ltd.
First posted: 2024-01-09
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Major Adverse Cardiovascular Events (MACE)
timeFrame: 12 months
Secondary outcomes:
measure: Cardiovascular Death
timeFrame: 3 months, 6 months, 12 months, 24 months, 36 months
measure: Non-fatal Myocardial Infarction
timeFrame: 3 months, 6 months, 12 months, 24 months, 36 months
measure: Target Lesion Revascularization (TLR)
timeFrame: 3 months, 6 months, 12 months, 24 months, 36 months
measure: Target Vessel Failure (TVF)
timeFrame: 3 months, 6 months, 12 months, 24 months, 36 months
measure: Restenosis
timeFrame: 3 months
measure: Major bleeding
timeFrame: 3 months, 6 months, 12 months, 2 years and 3 years
measure: Quality of Life Score
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Device success
timeFrame: During the procedure
Other outcomes:
Locations:
city: Ruse
country: Bulgaria
facility: Medica Core Heart Hopsital
Study officials:
References: