NCT05292144|CompletedDMC
Xperience Pro PMCF Study
rEPIC04A
Xperience Pro Post-Market Clinical Follow-up Study
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rEPIC04A
Xperience Pro Post-Market Clinical Follow-up Study
Sponsor study identifier
observational
46
1 country
5
Study Start
October 26, 2022
Actual (reported)Primary Completion
April 26, 2023
Actual (reported)Study Completion
May 5, 2023
Actual (reported)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 .
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 5, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 14, 2022
Actual (reported)March 23, 2022
Actual (reported)October 26, 2022
Actual (reported)April 26, 2023
Actual (reported)May 5, 2023
Actual (reported)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
Efficacy Endpoint. Freedom from Target Lesion Failure
7 days
Freedom from Balloon rupture
During percutaneous coronary intervention (PCI)
Freedom from Hypotube rupture
During PCI
Freedom from Complicated withdrawal
During PCI
Freedom from Coronary perforation
During PCI
Patients in whom treatment with (Xperience Pro) has been attempted
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients treated with Xperience pro according to routine hospital practice and following instructions for use
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario de Getafe
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
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.
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.
46 participants (actual enrollment reported by the registry).
First Submitted
March 14, 2022
First Posted
March 23, 2022
Study Start
October 26, 2022
Actual (reported)Contact the study team to confirm eligibility.
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.
Primary Completion
April 26, 2023
Actual (reported)Study Completion
May 5, 2023
Actual (reported)Last Updated
May 30, 2023
Record last verified: 2023-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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