NC Xperience PMCF Study( rEPIC04B) (rEPIC04B)
January 30, 2024 updated by: Fundación EPIC
NC Xperience Post-Market Clinical Follow-up Study
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 .
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
59
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Barcelona, Spain, 08036
- Hospital Clinic de Barcelona
-
Getafe, Spain, 28905
- Hospital Universitario de Getafe
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Santander, Spain, 39008
- Hospital Universitario Marqués de Valdecilla
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients treated with NC Xperience according to routine hospital practice and following instructions for use
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Coronary Artery Disease (CAD)
|
Coronary dilatation balloon catheter (non compliant)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety Endpoint. Freedom from Target Lesion Failure
Time Frame: 7 days
|
Freedom from composite of cardiac death, myocardial infarction (MI) and Target Lesion Revascularization (TLR)
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Freedom from Complicated withdrawal
Time Frame: During PCI
|
Freedom from Complicated withdrawal
|
During PCI
|
|
Freedom from Coronary perforation
Time Frame: During PCI
|
Freedom from Coronary perforation
|
During PCI
|
|
Freedom from Coronary dissection >C
Time Frame: During PCI
|
Freedom from Coronary dissection >C
|
During PCI
|
|
Freedom from No reflow
Time Frame: During PCI
|
Freedom from No reflow
|
During PCI
|
|
Freedom from Coronary thrombosis
Time Frame: During PCI
|
Freedom from Coronary thrombosis
|
During PCI
|
|
Efficacy Endpoint. freedom from Target Lesion Failure
Time Frame: 7 days
|
Freedom from composite of cardiac death, myocardial infarction (MI)and new Target Lesion Revascularization (TLR)
|
7 days
|
|
Freedom from Balloon rupture
Time Frame: During percutaneous coronary intervention (PCI)
|
Freedom from Balloon rupture
|
During percutaneous coronary intervention (PCI)
|
|
Freedom from Hypotube rupture
Time Frame: During PCI
|
Freedom from Hypotube rupture
|
During PCI
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 26, 2022
Primary Completion (Actual)
April 26, 2023
Study Completion (Actual)
May 5, 2023
Study Registration Dates
First Submitted
March 14, 2022
First Submitted That Met QC Criteria
March 14, 2022
First Posted (Actual)
March 23, 2022
Study Record Updates
Last Update Posted (Estimated)
January 31, 2024
Last Update Submitted That Met QC Criteria
January 30, 2024
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NC Xperience PMCF Study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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