Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Single center, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Essential Pro to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Essential Pro.
This study intends to analyze:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary Artery Disease (CAD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Essential pro | Device | Patients in whom treatment with (Essential Pro) has been attempted |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint. Freedom from Target Lesion Failure | Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR). Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Endpoint. Freedom from Target Lesion Failure (TLF) | Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR). | 12 months |
| Freedom from Balloon rupture |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients treated with Essential Pro according to routine hospital practice and following instructions for use
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| FUNDACION EPIC | Contact | 0034987225638 | iepic@fundacionepic.org |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Hospital | Recruiting | Lai Chi Kok | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 74678 | Background | Gruntzig A. Transluminal dilatation of coronary-artery stenosis. Lancet. 1978 Feb 4;1(8058):263. doi: 10.1016/s0140-6736(78)90500-7. No abstract available. | |
| 33953973 | Background | Wu X, Li L, He L. Drug-Coated Balloon versus Drug-Eluting Stent in Patients with Small-Vessel Coronary Artery Disease: A Meta-Analysis of Randomized Controlled Trials. Cardiol Res Pract. 2021 Apr 13;2021:1647635. doi: 10.1155/2021/1647635. eCollection 2021. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Freedom from Balloon rupture
| During PCI |
| Freedom from Hypotube rupture | Freedom from Hypotube rupture | During PCI |
| Freedom from Complicated withdrawal | Freedom from Complicated withdrawal | During PCI |
| Freedom from Coronary perforation | Freedom from Coronary perforation | During PCI |
| Freedom from Coronary dissection >C | Freedom from Coronary dissection >C | During PCI |
| Freedom from No reflow | Freedom from No reflow | During PCI |
| Freedom from Coronary thrombosis | Freedom from Coronary thrombosis | During PCI |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |