Coronary Artery Disease
Conditions
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.
Interventions
DEVICEMozec™ 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.
Sponsors
Meril Life Sciences Pvt. Ltd.
University National Heart Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiovascular Events (MACE) | 12 months | Composite of non-fatal MI, cardiovascular death, and target lesion revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-fatal Myocardial Infarction | 3 months, 6 months, 12 months, 24 months, 36 months | Non-fatal myocardial infarction (MI) is defined as per the fourth universal definition of MI |
| Target Lesion Revascularization (TLR) | 3 months, 6 months, 12 months, 24 months, 36 months | 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 |
| Target Vessel Failure (TVF) | 3 months, 6 months, 12 months, 24 months, 36 months | It is defined as the composite of cardiovascular death, target vessel myocardial infarction and target vessel revascularization |
| Cardiovascular Death | 3 months, 6 months, 12 months, 24 months, 36 months | Defined as per Academic Research Consortium-2 (ARC-2) criteria |
| Major bleeding | 3 months, 6 months, 12 months, 2 years and 3 years | Defined as bleeding that causes hemodynamic instability and/or leads to blood transfusion |
| Quality of Life Score | Baseline, 3 months, 6 months, 12 months | OverallHealthStatusassessedbyShortFormSurvey(SF-12) |
| Device success | During the procedure | Defined as the ability of the study device to be delivered, dilated, and retrieved from the target lesion |
| Restenosis | 3 months | Defined as \>50% stenosis at the treated segment. |
Countries
Bulgaria
Contacts
Primary ContactDobrin Vassilev, MD, PhD
Outcome results
None listed