Clinical trial NCT05292144: Xperience Pro PMCF Study
Official title: Xperience Pro Post-Market Clinical Follow-up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease (CAD)
Ischemic Heart Disease
Keywords: MDR (Medical Device Regulations)
PMCF (Post-Market Clinical Follow-up)
Coronary balloon dilatation catheter
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with Xperience pro according to routine hospital practice and following instructions for use

Brief summary: 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 .

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patient treated with Xperience pro according to routine hospital practice and following instructions for use
* Informed consent signed

Exclusion Criteria:

* Not meet inclusion criteria

Primary outcomes:
measure: Safety Endpoint. Freedom from Target Lesion Failure
timeFrame: 7 days
Secondary outcomes:
measure: Efficacy Endpoint. Freedom from Target Lesion Failure
timeFrame: 7 days
measure: Freedom from Balloon rupture
timeFrame: During percutaneous coronary intervention (PCI)
measure: Freedom from Hypotube rupture
timeFrame: During PCI
measure: Freedom from Complicated withdrawal
timeFrame: During PCI
measure: Freedom from Coronary perforation
timeFrame: During PCI
measure: Freedom from Coronary dissection >C
timeFrame: During PCI
measure: Freedom from No reflow
timeFrame: During PCI
measure: Freedom from Coronary thrombosis
timeFrame: During PCI
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Valme
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.