de Novo Stenotic Lesions in Native Coronary ArteriesNIRTRAKSNCT02455804

NIRTRAKS Post-Market Study (NIRTRAKS)

A study testing Stenting procedure in people with de Novo Stenotic Lesions in Native Coronary Arteries, run by Medinol Ltd. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a prospective, post-marketing, non-randomized, multi-center, single-arm clinical study that will be conducted at up to 15 sites in the United States (US). All subjects will be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3 years post-index stenting procedure. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: de Novo Stenotic Lesions in Native Coronary Arteries
What is being tested?: Stenting procedure
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 1 siteUnited States
Study dates: 8 Jan 2016to 14 Jan 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

General
Subject is ≥18 years old.
Subject is eligible for percutaneous coronary intervention (PCI).
Subject is eligible for dual anti-platelet therapy (DAPT) with aspirin plus either clopidogrel, prasugrel or ticagrelor for a minimum of 1 month.
Subject understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.
Subject is willing to comply with specified follow-up evaluation and can be contacted by telephone.

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Subject is an acceptable candidate for coronary artery bypass graft (CABG) surgery.
Subject has stable angina pectoris (Canadian Cardiovascular Society Classification [CCSC] 1, 2, 3 or 4) or unstable angina pectoris (Braunwald Class 1-3, B-C) or a positive functional ischemia study (e.g. exercise tolerance test [ETT], single-photon emission computerized tomography [SPECT], stress echocardiography or cardiac computerized tomography [CT]).
Female subjects of child bearing potential must have a negative pregnancy test within 7 days prior to enrollment in the study.
Angiographic Inclusion Criteria
Subject is indicated for elective stenting of a single stenotic lesion in a native coronary artery.
Reference vessel ≥2.5 mm and ≤4.0 mm in diameter by visual estimate.
Target lesion ≤30 mm in length by visual estimate (the intention should be to cover the whole lesion with 1 stent of adequate length).
Target lesion stenosis ≥50% and <100% by visual estimate.

Who cannot join

General Exclusion Criteria
Subject is currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
Subject was enrolled in another stent trial within 2 years prior to the index procedure.
Any planned elective surgery or percutaneous intervention within 9 months post- procedure.
A previous coronary interventional procedure of any kind within 30 days prior to the procedure.
The subject requires staged procedure of either the target vessel or any non-target vessel within 9 months post-procedure.

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The target lesion requires treatment with a device other than percutaneous transluminal coronary angioplasty (PTCA) prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).
Previous drug-eluting stent (DES) deployment anywhere in the target vessel.
Any previous DES deployment within the past 12 months.
Any previous stent placement within 15 mm proximal or distal to the target lesion.
Co-morbid condition(s) that could limit the subject's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.
Concurrent medical condition with a life expectancy of <3 years.
Documented left ventricular ejection fraction (LVEF) <25% at the most recent evaluation.
Evidence of an acute MI within 72 hours of the intended index procedure.
History of cerebrovascular accident or transient ischemic attack within 6 months prior to the index procedure.
Leukopenia (leukocytes <3.5 x 109/liter).
Neutropenia (absolute neutrophil count <1,000/mm3) ≤ within 7 days prior to enrollment.
Thrombocytopenia (platelets <100,000/mm3) pre-procedure (within 7 days prior to enrollment).
Active peptic ulcer or active gastrointestinal (GI) bleeding.
Subjects who are ineligible for ≥1 month of DAPT because of bleeding diathesis or any other reason.
Known hypersensitivity or contraindication to aspirin, thienopyridine, both heparin and bivalirudin, cobalt, nickel, L-605 cobalt chromium alloy or sensitivity to contrast media which cannot be adequately pre-medicated.
Serum creatinine level >2.5 mg/dL within 7 days prior to the index procedure.
Subject was previously enrolled in the PIONIR Study or the NIRTRAKS Post-Market Study.
Angiographic Exclusion Criteria
Unprotected left main coronary artery disease (obstruction >50% in the left main coronary artery that is not protected by ≥1 non-obstructed bypass graft to the left anterior descending [LAD] or left circumflex [LCX] artery or a branch thereof).
Target vessel exhibiting multiple lesions with >60% diameter stenosis outside of a range of 5 mm proximal and distal to the target lesion based on visual estimate or on-line quantitative coronary angiography (QCA).
Target lesion exhibiting an intraluminal thrombus (occupying >50% of the true lumen diameter) at any time prior to the start of the intervention.
Lesion location that is aorto-ostial or within 5 mm of the origin of the LAD or LCX.
Target lesion with side branches >2.0 mm in diameter.
Target lesion involving a bifurcation (either stenosis of both main vessel and major branch or stenosis of just major branch).
Target lesion with severe calcification.
Target vessel exhibiting excessive tortuosity that may impede stent delivery and deployment at target lesion.
Target lesion that is located in a native vessel distal to an anastomosis with a saphenous vein graft or a left/right internal mammary artery (LIMA/RIMA) bypass.

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Health System
Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: NIRTRAKS - (NIRxcell TRial for a Post mArKet Study)

Read the detailed description

The main objective of this study is to collect and analyze additional information about the safety and effectiveness of the NIRxcell Stent System in the treatment of de novo stenotic lesions in native coronary arteries in the US population. The primary endpoint will be the rate of target vessel failure (TVF) at 3 years of treatment with the NIRxcell Stent System. This rate will be compared with a performance goal derived from a meta-analysis of coronary stenting with bare metal stents (BMS).

Conditions: de Novo Stenotic Lesions in Native Coronary Arteries
Being tested: Stenting procedure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Stenting procedureDevice
All subjects will be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3 years post-index stenting procedure. An unscheduled follow up may be conducted as clinically warranted.

Study groups in NCT02455804
Study group	Role	What they receive
Single Arm	Other	This is a prospective, post-marketing, non-randomized, multi-center, single-arm clinical study that will be conducted at up to 15 sites in the United States (US). All subjects will be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3 years post-index stenting procedure. An unscheduled follow up may be conducted as clinically warranted. Receives: Device: Stenting procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

Target Vessel Failure
The primary endpoint in this study was TVF (Target Vessel Failure) defined as a composite of cardiac death, target vessel myocardial infarction (MI), or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods within 3 years post-procedure.
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jan 201614 Jan 2020

First posted28 May 2015 (estimated)
Study start8 Jan 2016
Primary completion14 Jan 2020
Study completion14 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for de Novo Stenotic Lesions in Native Coronary ArteriesStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02455804
Sponsor's protocol ID: CV103-02
Acronym: NIRTRAKS
Status last verified: Oct 2023
First submitted: 26 May 2015
Last updated: 4 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: NIRTRAKS - (NIRxcell TRial for a Post mArKet Study)
ClinicalTrials.gov ID: NCT02455804
Acronym / sponsor ID: NIRTRAKS / CV103-02
Conditions: de Novo Stenotic Lesions in Native Coronary Arteries
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Medinol Ltd.Industry (pharma, biotech, devices)
Study start: 8 Jan 2016 (actual)
Primary completion: 14 Jan 2020 (actual)
Study completion: 14 Jan 2020 (actual)
First posted: 28 May 2015 (estimated)
Results: Posted 4 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single Arm	Other	Device: Stenting procedureThis is a prospective, post-marketing, non-randomized, multi-center, single-arm clinical study that will be conducted at up to 15 sites in the United States (US). All subjects will be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3 years post-index stenting procedure. An unscheduled follow up may be conducted as clinically warranted.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

General
Subject is ≥18 years old.
Subject is eligible for percutaneous coronary intervention (PCI).
Subject is eligible for dual anti-platelet therapy (DAPT) with aspirin plus either clopidogrel, prasugrel or ticagrelor for a minimum of 1 month.
Subject understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.

Key exclusion criteria (33 listed)

General Exclusion Criteria
Subject is currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
Subject was enrolled in another stent trial within 2 years prior to the index procedure.
Any planned elective surgery or percutaneous intervention within 9 months post- procedure.
A previous coronary interventional procedure of any kind within 30 days prior to the procedure.

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
Stenting procedureAll subjects will be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3 years post-index stenting procedure. An unscheduled follow up may be conducted as clinically warranted.	Device	Single Arm

Primary outcome

Target Vessel Failure
Time frame: 3 years
The primary endpoint in this study was TVF (Target Vessel Failure) defined as a composite of cardiac death, target vessel myocardial infarction (MI), or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods within 3 years post-procedure.

Results and safety

Results posted to the registry on 4 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Arm	65	46

Primary outcome: Target Vessel Failure

Time frame: 3 years. Number (95% Confidence Interval). Unit: percentage of TVF

Measure	Single Arm n = 61
Value	15 (14.5 to 37.3)

Adverse events

Time frame: Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Arm	40 of 65 (61.5%)	58 of 65 (89.2%)	0 of 65

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Manesh R Patel, MD, FACC principal investigator

Duke Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Stenting procedure in people with de Novo Stenotic Lesions in Native Coronary Arteries, run by Medinol Ltd. at 1 site in United States.

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 14 inclusion and 33 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 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Yes. Results are posted in the registry (first posted 4 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Target Vessel Failure (time frame: 3 years). 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 NCT02455804.

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 4 Oct 2023.