NIRTRAKS Post-Market Study (NIRTRAKS) (NIRTRAKS)

NIRTRAKS - (NIRxcell TRial for a Post mArKet Study)

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.

Study Overview

• Status: Completed
• Conditions: de Novo Stenotic Lesions in Native Coronary Arteries
• Intervention / Treatment: Device: Stenting procedure

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).

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

General

1. Subject is ≥18 years old.
2. Subject is eligible for percutaneous coronary intervention (PCI).
3. Subject is eligible for dual anti-platelet therapy (DAPT) with aspirin plus either clopidogrel, prasugrel or ticagrelor for a minimum of 1 month.
4. Subject understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.
5. Subject is willing to comply with specified follow-up evaluation and can be contacted by telephone.
6. Subject is an acceptable candidate for coronary artery bypass graft (CABG) surgery.
7. 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]).
8. Female subjects of child bearing potential must have a negative pregnancy test within 7 days prior to enrollment in the study.

Angiographic Inclusion Criteria

1. Subject is indicated for elective stenting of a single stenotic lesion in a native coronary artery.
2. Reference vessel ≥2.5 mm and ≤4.0 mm in diameter by visual estimate.
3. Target lesion ≤30 mm in length by visual estimate (the intention should be to cover the whole lesion with 1 stent of adequate length).
4. Target lesion stenosis ≥50% and <100% by visual estimate.

Exclusion Criteria:

General Exclusion Criteria

1. 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.
2. Subject was enrolled in another stent trial within 2 years prior to the index procedure.
3. Any planned elective surgery or percutaneous intervention within 9 months post- procedure.
4. A previous coronary interventional procedure of any kind within 30 days prior to the procedure.
5. The subject requires staged procedure of either the target vessel or any non-target vessel within 9 months post-procedure.
6. 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.).
7. Previous drug-eluting stent (DES) deployment anywhere in the target vessel.
8. Any previous DES deployment within the past 12 months.
9. Any previous stent placement within 15 mm proximal or distal to the target lesion.
10. 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.
11. Concurrent medical condition with a life expectancy of <3 years.
12. Documented left ventricular ejection fraction (LVEF) <25% at the most recent evaluation.
13. Evidence of an acute MI within 72 hours of the intended index procedure.
14. History of cerebrovascular accident or transient ischemic attack within 6 months prior to the index procedure.
15. Leukopenia (leukocytes <3.5 x 109/liter).
16. Neutropenia (absolute neutrophil count <1,000/mm3) ≤ within 7 days prior to enrollment.
17. Thrombocytopenia (platelets <100,000/mm3) pre-procedure (within 7 days prior to enrollment).
18. Active peptic ulcer or active gastrointestinal (GI) bleeding.
19. Subjects who are ineligible for ≥1 month of DAPT because of bleeding diathesis or any other reason.
20. 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.
21. Serum creatinine level >2.5 mg/dL within 7 days prior to the index procedure.
22. Subject was previously enrolled in the PIONIR Study or the NIRTRAKS Post-Market Study.

Angiographic Exclusion Criteria

1. 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).
2. 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).
3. Target lesion exhibiting an intraluminal thrombus (occupying >50% of the true lumen diameter) at any time prior to the start of the intervention.
4. Lesion location that is aorto-ostial or within 5 mm of the origin of the LAD or LCX.
5. Target lesion with side branches >2.0 mm in diameter.
6. Target lesion involving a bifurcation (either stenosis of both main vessel and major branch or stenosis of just major branch).
7. Target lesion with severe calcification.
8. Target vessel exhibiting excessive tortuosity that may impede stent delivery and deployment at target lesion.
9. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single Arm; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medinol Ltd.
• Investigators: Principal Investigator: Manesh R Patel, MD, FACC, Duke Health

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2016
• Primary Completion (Actual): January 14, 2020
• Study Completion (Actual): January 14, 2020

Study Registration Dates

• First Submitted: May 26, 2015
• First Submitted That Met QC Criteria: May 26, 2015
• First Posted (Estimated): May 28, 2015

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CV103-02