A Prospective, Multi-Center, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions

A Prospective, Multi-Center, Non-randomized, Single Arm, Open Label, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions

This study evaluates the safety and effectiveness of the a novel device called NovaCross to help cross Chronic Total Occlusion (CTO) lesions in coronary arteries.

Study Overview

• Status: Completed
• Conditions: Chronic Total Occlusion of Coronary Artery
• Intervention / Treatment: Device: NovaCross

Detailed Description

The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross™ micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries. The procedure will be conducted on consenting patients diagnosed with a CTO in a coronary vessel that requires revascularization after a previously failed attempt to cross or refractory to 10 minutes of conventional guidewire attempt.

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Krakow, Poland
    • SPZOZ University Hospital in Krakow
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Central Arkansas Veterans Healthcare System
  • Illinois
    • Naperville, Illinois, United States, 60540
      • Edward Hospital
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center/New York Presbyterian Hospital
  • Pennsylvania
    • York, Pennsylvania, United States, 17403
      • York Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult aged 25-80
• Patient understands and has signed the study informed consent form.
• Patient has an angiographic documented Chronic Total Occlusion (i.e. >3 months occlusion duration) showing distal TIMI flow 0.
• Suitable candidate for non-emergent, coronary angioplasty
• Documented coronary angiography preceding the PCI reveals at least one CTO lesion situated in a non-infarct related coronary artery or its side branches
• Body Mass Index (BMI) < 40
• Left ventricle ejection fraction > 25%

Exclusion Criteria:

• Patient unable to give informed consent.
• Current participation in another study with any investigational drug or device.
• Patient is known or suspected not to tolerate the contrast agent.
• Aorta-ostial CTO location (Ostial bifurcation origins may be considered), SVG CTO, in-stent CTO.
• Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor).
• Appearance of a fresh thrombus or intraluminal filling defects.
• Recent major cerebrovascular event (history of stroke or TIA within 1 month)
• Cardiac intervention within 4 weeks of the procedure
• Renal insufficiency (serum creatinine of > 2.3mg/dl or 203μmol/L)
• Active gastrointestinal bleeding
• Active infection or fever that may be due to infection
• Life expectancy < 2 years due to other illnesses
• Significant anemia (hemoglobin < 8.0 mg / dl)
• Severe uncontrolled systemic hypertension (> 240 mmHg within 1 month of procedure)
• Severe electrolyte imbalance
• Congestive heart failure [New York Heart Association (NYHA) Class III\IV] CSA Class IV.
• Unstable angina requiring emergent percutaneous trans-luminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG)
• Recent myocardial infarction (MI) (within the past two weeks)
• Uncontrolled diabetes >2 serum glucose concentrations of >350 mg/dl within 7 days.
• Unwillingness or inability to comply with any protocol requirements
• Pregnant or nursing
• Extensive prior dissection from a coronary guidewire use
• Drug abuse or alcoholism.
• Patients under custodial care.
• Bleeding diathesis or coagulation disorder;
• Kawasaki's disease or other vasculitis

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
Experimental: NovaCross; NovaCross microcatheter will be used.	Device: NovaCross; The NovaCross™ is a guidewire positioning and support microcatheter for improving chronic total occlusion (CTO) crossability. The NovaCross™ gains its supportive characteristics through the use of a unique operator-controlled Nitinol scaffold and an extendable segment, both at its distal tip.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	30 day MACE, defined as the composite of death, myocardial infarction (MI), or urgent revascularization (target vessel revascularization (TVR) or urgent coronary artery bypass surgery (CABG)).	30 days
Intra-procedural technical success	Intra-procedural technical success, defined as the ability of the NovaCross™ micro-catheter to successfully facilitate placement of a guidewire beyond a native coronary chronic total occlusion (CTO) in the true vessel lumen.	Intra-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. The ability to cross the lesion with a guidewire in the true lumen, effectively dilate the CTO lesion, and place a coronary stent with residual lumen stenosis of less than 30% while restoring antegrade TIMI 3 flow.	1. The ability to cross the lesion with a guidewire in the true lumen, effectively dilate the CTO lesion, and place a coronary stent with residual lumen stenosis of less than 30% while restoring antegrade TIMI 3 flow.	Procedure
Proximal cap (ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO.)	2. The ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO.	Procedure
Effectiveness of extendable portion (effectiveness of the extendable portion in intra-CTO microcatheter crossability)	3. The effectiveness of the extendable portion in intra-CTO microcatheter crossability.	Procedure
Visualization (ability to have full visualization of the NovaCross during the CTO procedure)	4. The ability to have full visualization of the NovaCross during the CTO procedure.	Procedure
Usability (Assess the usability of the NovaCross™ by the operator)	5. Assess the usability of the NovaCross™ by the operator.	Procedure
Device-related perforation (at the site of target coronary lesion and/or its proximal reference segment)	6. Device-related perforation at the site of target coronary lesion and/or its proximal reference segment.	Procedure

Collaborators and Investigators

• Sponsor: Nitiloop Ltd.
• Investigators: Principal Investigator: Simon Walsh, MD, Belfast Health and Social Care Trust

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2015
• Primary Completion (Actual): August 10, 2017
• Study Completion (Actual): August 10, 2017

Study Registration Dates

• First Submitted: June 17, 2015
• First Submitted That Met QC Criteria: June 22, 2015
• First Posted (Estimate): June 23, 2015

Study Record Updates

• Last Update Posted (Actual): August 17, 2017
• Last Update Submitted That Met QC Criteria: August 14, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: NT-CLP-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No