NCT05292105

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 23, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

September 26, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2023

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

March 14, 2022

Last Update Submit

January 30, 2024

Conditions

Coronary Artery Disease (CAD)Ischemic Heart Disease

Keywords

MDR (Medical Device Regulations)PMCF (Post-Market Clinical Follow-up)Coronary balloon dilatation catheter

Outcome Measures

Primary Outcomes (1)

  • Safety Endpoint. Freedom from Target Lesion Failure

    Freedom from composite of cardiac death, myocardial infarction (MI) and Target Lesion Revascularization (TLR)

    7 days

Secondary Outcomes (8)

  • Efficacy Endpoint. freedom from Target Lesion Failure

    7 days

  • Freedom from Balloon rupture

    During percutaneous coronary intervention (PCI)

  • Freedom from Hypotube rupture

    During PCI

  • Freedom from Complicated withdrawal

    During PCI

  • Freedom from Coronary perforation

    During PCI

  • +3 more secondary outcomes

Study Arms (1)

Coronary Artery Disease (CAD)

Device: NC Xperience

Interventions

NC XperienceDEVICE

Coronary dilatation balloon catheter (non compliant)

Coronary Artery Disease (CAD)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated with NC Xperience according to routine hospital practice and following instructions for use

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario de Getafe

Getafe, 28905, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Related Publications (6)

  • 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.

    PMID: 74678BACKGROUND

  • 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.

    PMID: 12772236BACKGROUND

  • 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.

    PMID: 29450169BACKGROUND

  • 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.

    PMID: 23703842BACKGROUND

  • 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.

    PMID: 25480993BACKGROUND

  • 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.

    PMID: 25733175BACKGROUND

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2022

First Posted

March 23, 2022

Study Start

September 26, 2022

Primary Completion

April 26, 2023

Study Completion

May 5, 2023

Last Updated

January 31, 2024

Record last verified: 2023-01

Locations

ES(3)