Clinical trial NCT05292105: NC Xperience PMCF Study( rEPIC04B)
Official title: NC Xperience 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: 59
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 NC Xperience 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 NC Xperience to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with NC Xperience .

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 NC Xperience 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 NC Xperience 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: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
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: Brodie BR, Cooper C, Jones M, Fitzgerald P, Cummins F; Postdilatation Clinical Compartative Study (POSTIT) Investigators. Is adjunctive balloon postdilatation necessary after coronary stent deployment? Final results from the POSTIT trial. Catheter Cardiovasc Interv. 2003 Jun;59(2):184-92. doi: 10.1002/ccd.10474.
citation: Chandrasekhar J, Allada C, O'Connor S, Rahman M, Shadbolt B, Farshid A. Efficacy of non-compliant balloon post-dilation in optimization of contemporary stents: A digital stent enhancement study. Int J Cardiol Heart Vessel. 2014 Mar 19;3:43-48. doi: 10.1016/j.ijchv.2014.03.006. eCollection 2014 Jun.
citation: Pasceri V, Pelliccia F, Pristipino C, Roncella A, Irini D, Varveri A, Bisciglia A, Speciale G. Clinical effects of routine postdilatation of drug-eluting stents. Catheter Cardiovasc Interv. 2014 May 1;83(6):898-904. doi: 10.1002/ccd.24999. Epub 2013 Dec 18.
citation: Rana O, Shah NC, Wilson S, Swallow R, O'Kane P, Levy T. The impact of routine and intravascular ultrasound-guided high-pressure postdilatation after drug-eluting stent deployment: the STent OPtimization (STOP) study. J Invasive Cardiol. 2014 Dec;26(12):640-6.
citation: Kim BG, Cho SW, Kim DH, Kim JH, Byun YS, Goh CW, Rhee KJ, Lee BK, Kim BO. Stent length is a contributing factor of suboptimal stent expansion in drug-eluting stents. Kardiol Pol. 2015;73(8):598-605. doi: 10.5603/KP.a2015.0034. Epub 2015 Mar 3.