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

N/AUnknownNCT06197022

University National Heart Hospital106 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

106

Conditions

Coronary Artery Disease

Interventions

Mozec™ SEB Sirolimus Eluting Rx PTCA Balloon Dilatation Catheter

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Major Adverse Cardiovascular Events (MACE)

Composite of non-fatal MI, cardiovascular death, and target lesion revascularization

Time frame: 12 months

Secondary Outcomes

Cardiovascular Death

Defined as per Academic Research Consortium-2 (ARC-2) criteria

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 3 months, 6 months, 12 months, 24 months, 36 months

Restenosis

Defined as \>50% stenosis at the treated segment.

Time frame: 3 months

Major bleeding

Defined as bleeding that causes hemodynamic instability and/or leads to blood transfusion

Time frame: 3 months, 6 months, 12 months, 2 years and 3 years

Quality of Life Score

OverallHealthStatusassessedbyShortFormSurvey(SF-12)

Time frame: 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

Time frame: During the procedure

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts