NC Xperience PMCF Study( rEPIC04B)

Ischemic Heart Disease Clinical Trial

— rEPIC04B  

Official title:

NC Xperience Post-Market Clinical Follow-up Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05292105
• Other study ID #: NC Xperience PMCF Study
• Status: Completed
• Start date: September 26, 2022
• Est. completion date: May 5, 2023

Study information

• Verified date: January 2023
• Source: Fundación EPIC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: May 5, 2023
• Est. primary completion date: April 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease (CAD)
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Device:
• NC Xperience
Coronary dilatation balloon catheter (non compliant)

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Universitario de Getafe	Getafe
Spain	Hospital Universitario Marques de Valdecilla	Santander

Sponsors (1)

Lead Sponsor	Collaborator
Fundación EPIC

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Endpoint. Freedom from Target Lesion Failure	Freedom from composite of cardiac death, myocardial infarction (MI) and Target Lesion Revascularization (TLR)	7 days
Secondary	Efficacy Endpoint. freedom from Target Lesion Failure	Freedom from composite of cardiac death, myocardial infarction (MI)and new Target Lesion Revascularization (TLR)	7 days
Secondary	Freedom from Balloon rupture	Freedom from Balloon rupture	During percutaneous coronary intervention (PCI)
Secondary	Freedom from Hypotube rupture	Freedom from Hypotube rupture	During PCI
Secondary	Freedom from Complicated withdrawal	Freedom from Complicated withdrawal	During PCI
Secondary	Freedom from Coronary perforation	Freedom from Coronary perforation	During PCI
Secondary	Freedom from Coronary dissection >C	Freedom from Coronary dissection >C	During PCI
Secondary	Freedom from No reflow	Freedom from No reflow	During PCI
Secondary	Freedom from Coronary thrombosis	Freedom from Coronary thrombosis	During PCI