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 Xperience Pro to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Xperience Pro .
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 Xperience Pro 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 |
|---|---|---|---|---|
| Xperience Pro | Device | Patients in whom treatment with (Xperience 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 and and new Target Lesion Revascularization (TLR) | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Endpoint. Freedom from Target Lesion Failure | Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction (MI) and and new Target Lesion Revascularization (TLR). | 7 days |
| Freedom from Balloon rupture |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients treated with Xperience pro according to routine hospital practice and following instructions for use
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain | |||
| Hospital Universitario de Getafe |
| 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. | |
| 21351225 | Background | Kandzari DE, Zankar AA, Teirstein PS, Brilakis ES, Banerjee S, Price MJ, Stinis CT, Hudson PA, Dahle TG, Eng M, Brown R, Ferguson A, Addo TA, Popma JJ. Clinical outcomes following predilation with a novel 1.25-mm diameter angioplasty catheter. Catheter Cardiovasc Interv. 2011 Mar 1;77(4):510-4. doi: 10.1002/ccd.22734. Epub 2010 Nov 4. |
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 percutaneous coronary intervention (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 |
| Getafe |
| 28905 |
| Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario Marques de Valdecilla | Santander | 39008 | Spain |
| Hospital Universitario Virgen de Valme | Seville | 41014 | Spain |
| 23369084 | Background | Kandzari DE, Teirstein PS, Kereiakes DJ, Cannon LA, Hearne SE, Kuo HC, Ying SW, Cheong WF, Popma JJ. Procedural effectiveness of a novel 1.20 mm diameter angioplasty catheter: clinical and angiographic outcomes. J Interv Cardiol. 2013 Apr;26(2):131-6. doi: 10.1111/j.1540-8183.2013.12021.x. Epub 2013 Jan 31. |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |