Coronary Artery Disease (CAD)rEPIC04BNCT05292105
NC Xperience PMCF Study( rEPIC04B)
An observational study of Coronary Artery Disease (CAD) and Ischemic Heart Disease, run by Fundación EPIC at 3 sites in Spain.
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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease (CAD), Ischemic Heart Disease
- What is being tested?
- NC Xperience
- Type of treatment
- Medical device
- How many people
- 59 participants
- Where
- 3 sitesSpain
- Study dates
- 26 Sep 2022to 5 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with NC Xperience according to routine hospital practice and following instructions for use
Who may be able to join
- Patient treated with NC Xperience according to routine hospital practice and following instructions for use
- Informed consent signed
Who cannot join
- Not meet inclusion criteria
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Universitario de Getafe
Getafe, 28905
Hospital Universitario Marques de Valdecilla
Santander, 39008
About this study
Official title: 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 .
Read the 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.
- Being tested
- NC Xperience
- Keywords
- MDR (Medical Device Regulations), PMCF (Post-Market Clinical Follow-up), Coronary balloon dilatation catheter
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NC XperienceDevice
Coronary dilatation balloon catheter (non compliant)
| Study group | Role | What they receive |
|---|---|---|
| Coronary Artery Disease (CAD) | Not described Receives: Device: NC Xperience |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoint. Freedom from Target Lesion Failure
Freedom from composite of cardiac death, myocardial infarction (MI) and Target Lesion Revascularization (TLR)
Measured: 7 days
Secondary outcomes (8)
Efficacy Endpoint. freedom from Target Lesion Failure
Freedom from composite of cardiac death, myocardial infarction (MI)and new Target Lesion Revascularization (TLR)
Measured: 7 days
Freedom from Balloon rupture
Freedom from Balloon rupture
Measured: During percutaneous coronary intervention (PCI)
Freedom from Hypotube rupture
Freedom from Hypotube rupture
Measured: During PCI
Freedom from Complicated withdrawal
Freedom from Complicated withdrawal
Measured: During PCI
Freedom from Coronary perforation
Freedom from Coronary perforation
Measured: During PCI
Freedom from Coronary dissection >C
Freedom from Coronary dissection >C
Measured: During PCI
Freedom from No reflow
Freedom from No reflow
Measured: During PCI
Freedom from Coronary thrombosis
Freedom from Coronary thrombosis
Measured: During PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start26 Sep 2022
- Primary completion26 Apr 2023
- Study completion5 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación EPIC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292105
- Sponsor's protocol ID
- NC Xperience PMCF Study
- Acronym
- rEPIC04B
- Status last verified
- Jan 2023
- First submitted
- 14 Mar 2022
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 74678Brodie 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.
PubMed 12772236Chandrasekhar 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.
PubMed 29450169Pasceri 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.
PubMed 23703842Rana 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.
PubMed 25480993Kim 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.
PubMed 25733175
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NC Xperience Post-Market Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT05292105
- Acronym / sponsor ID
- rEPIC04B / NC Xperience PMCF Study
- Keywords
- MDR (Medical Device Regulations), PMCF (Post-Market Clinical Follow-up), Coronary balloon dilatation catheter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Fundación EPICUniversity, hospital or other
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 23 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary Artery Disease (CAD) | – | Device: NC Xperience |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with NC Xperience according to routine hospital practice and following instructions for use
Key inclusion criteria (2 listed)
- Patient treated with NC Xperience according to routine hospital practice and following instructions for use
- Informed consent signed
Key exclusion criteria (1 listed)
- Not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NC XperienceCoronary dilatation balloon catheter (non compliant) | Device | Coronary Artery Disease (CAD) |
Primary outcome
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)
8 secondary outcomes
Efficacy Endpoint. freedom from Target Lesion Failure
Time frame: 7 days
Freedom from Balloon rupture
Time frame: During percutaneous coronary intervention (PCI)
Freedom from Hypotube rupture
Time frame: During PCI
Freedom from Complicated withdrawal
Time frame: During PCI
Freedom from Coronary perforation
Time frame: During PCI
Freedom from Coronary dissection >C
Time frame: During PCI
Freedom from No reflow
Time frame: During PCI
Freedom from Coronary thrombosis
Time frame: During PCI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Background: PubMed 74678Gruntzig 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.
- Background: PubMed 12772236Brodie 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.
- Background: PubMed 29450169Chandrasekhar 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.
- Background: PubMed 23703842Pasceri 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.
- Background: PubMed 25480993Rana 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.
- Background: PubMed 25733175Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease (CAD) and Ischemic Heart Disease, run by Fundación EPIC at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Endpoint. Freedom from Target Lesion Failure (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05292105, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.