NIRTRAKS Post-Market Study (NIRTRAKS)

NCT02455804 | Completed Results DMC

• 1 other identifier: CV103-02
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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. An unscheduled follow up may be conducted as clinically warranted.

Conditions

de Novo Stenotic Lesions in Native Coronary Arteries

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Study Arms (1)

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.

Device: Stenting procedure

Interventions

Stenting procedure DEVICE

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.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Medinol Ltd.: lead

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

Results Point of Contact

• Title: Dina Kofler, VP Clinical Affairs
• Organization: Medinol

dinak@medinol.com

+97237679032

Study Officials

• Manesh R Patel, MD, FACC

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: May 28, 2015
• Study Start: January 8, 2016
• Primary Completion: January 14, 2020
• Study Completion: January 14, 2020
• Last Updated: October 4, 2023
• Results First Posted: October 4, 2023

Record last verified: 2023-10

Locations

US (1)