Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Meril Life Sciences Pvt. Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scoring Balloon Angioplasty | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mozec™ SEB Sirolimus Eluting Rx PTCA Balloon Dilatation Catheter | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiovascular Events (MACE) | Composite of non-fatal MI, cardiovascular death, and target lesion revascularization | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Death | Defined as per Academic Research Consortium-2 (ARC-2) criteria | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dobrin Vassilev, MD, PhD | Contact | +3590886846550 | dobrinv@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medica Core Heart Hopsital | Recruiting | Rousse | 7000 | Bulgaria |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | 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 | 3 months, 6 months, 12 months, 24 months, 36 months |
| Restenosis | Defined as >50% stenosis at the treated segment. | 3 months |
| Major bleeding | Defined as bleeding that causes hemodynamic instability and/or leads to blood transfusion | 3 months, 6 months, 12 months, 2 years and 3 years |
| Quality of Life Score | OverallHealthStatusassessedbyShortFormSurvey(SF-12) | 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 | During the procedure |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided