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
Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Naviscore scoring balloon to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Naviscore.
The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Naviscore scoring balloon in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.
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 |
|---|---|---|---|---|
| Naviscore | Device | Patients in whom treatment with (Naviscore) 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). | 7 days |
| 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). | 7 days |
| Freedom from Balloon rupture |
Not provided
Inclusion Criteria:
Exclusion Criteria:
• Not meet inclusion criteria
Not provided
Not provided
Not provided
Not provided
Patients treated with Naviscore according to routine hospital practice and following instructions for use
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall D'Hebron | Barcelona | 08035 | Spain | |||
| Hospital Clinic de Barcelona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18174614 | Background | Fonseca A, Costa Jde R Jr, Abizaid A, Feres F, Abizaid AS, Costa R, Staico R, Mattos LA, Sousa AG, Grube E, Sousa JE. Intravascular ultrasound assessment of the novel AngioSculpt scoring balloon catheter for the treatment of complex coronary lesions. J Invasive Cardiol. 2008 Jan;20(1):21-7. | |
| 22927100 | Background |
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 (Percutaneous Coronary Intervention) |
| Freedom from Hypotube rupture | Freedom from Hypotube rupture ( partial or total fracture of the shaft of the device) | During PCI (Percutaneous Coronary Intervention) |
| Freedom from Complicated withdrawal | Freedom from Complicated withdrawal (difficult or impossible device retrieval that may or may not cause clinical complications) | During PCI (Percutaneous Coronary Intervention) |
| Freedom from Coronary perforation | Freedom from Coronary perforation according to the modified Ellis classification | During PCI (Percutaneous Coronary Intervention) |
| Freedom from Coronary dissection >C | Freedom from Coronary dissection >C according to the NHLBI Classification (National Heart, Lung, and Blood Institute) | During PCI (Percutaneous Coronary Intervention) |
| Freedom from No reflow | Freedom from No reflow (persistently slowed flow with residual stenosis <30% and no flow-limiting dissection) | During PCI (Percutaneous Coronary Intervention) |
| Freedom from Coronary thrombosis | Freedom from Coronary thrombosis according to ARC-2 ( Academic Research Consortium-2) criteria | During PCI (Percutaneous Coronary Intervention) |
| Barcelona |
| 08036 |
| Spain |
| Hospital Universitario de Cáceres | Cáceres | 10003 | Spain |
| Hospital Universitario Juan Ramon Jimenez | Huelva | 21005 | Spain |
| Hospital Universitario de Leon | León | 24008 | Spain |
| Hospital Universitario Lucus Agusti | Lugo | 27003 | Spain |
| Hospital Regional Universitario Carlos Haya | Málaga | 29010 | Spain |
| Weisz G, Metzger DC, Liberman HA, O'Shaughnessy CD, Douglas JS Jr, Turco MA, Mehran R, Gershony G, Leon MB, Moses JW. A provisional strategy for treating true bifurcation lesions employing a scoring balloon for the side branch: final results of the AGILITY trial. Catheter Cardiovasc Interv. 2013 Sep 1;82(3):352-9. doi: 10.1002/ccd.24630. Epub 2013 Mar 9. |
| Background | US FDA: Summary of Safety and Effectiveness Data (SSED): AngioSculpt®Scoring Balloon Catheter (2007) www.accessdata.fda.gov/cdrh_docs/pdf5/P050018b.pdf |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |