NC Xperience PMCF Study( rEPIC04B)

NCT ID: NCT05292105

Last Updated: 2024-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-26

Study Completion Date

2023-05-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease (CAD) Ischemic Heart Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Coronary Artery Disease (CAD)

NC Xperience

Intervention Type DEVICE

Coronary dilatation balloon catheter (non compliant)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NC Xperience

Coronary dilatation balloon catheter (non compliant)

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient treated with NC Xperience according to routine hospital practice and following instructions for use
* Informed consent signed
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fundación EPIC

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status

Hospital Universitario de Getafe

Getafe, , Spain

Site Status

Hospital Universitario Marques de Valdecilla

Santander, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 74678 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12772236 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29450169 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23703842 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25480993 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25733175 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NC Xperience PMCF Study

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

BioFreedom Pharmacokinetic Study
NCT03365492 COMPLETED NA
PEPCAD III Substudy: Stem Cell Mobilization
NCT00473499 COMPLETED PHASE1/PHASE2