Cohort B of the Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2019-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Coronary Occlusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is an open label, multi-center, prospective, supplemental study in which the device, NovaCross™ CTO micro-catheter, will be tested in up to 60 patients scheduled to undergo CTO-PCI using an anterograde approach

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NovaCross

the NovaCross is a guidewire positioning and support micro-catheter 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 extandable segment, both at its distal tip.

Group Type EXPERIMENTAL

NovaCross

Intervention Type DEVICE

The NovaCross micro-catheter will be used during a standard of care Percutanous Coronary Intervention (PCI) on subjects diagnosed with at least one coronary chronic total occlusion (CTO), in order to assist the operator in guidewire stability and centralization.

Interventions

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NovaCross

The NovaCross micro-catheter will be used during a standard of care Percutanous Coronary Intervention (PCI) on subjects diagnosed with at least one coronary chronic total occlusion (CTO), in order to assist the operator in guidewire stability and centralization.

Intervention Type DEVICE

Eligibility Criteria

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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, with a reference diameter of at least 2 millimeters.
* Left ventricle ejection fraction \> 25%

Exclusion Criteria

* Patient unable to give informed consent.
* Elevated CK-MB or troponin at baseline
* Patient is known or suspected not to tolerate the contrast agent
* Chronic Total Occlusion is located in aorto-ostial location, SVG CTO, in-stent occlusion
* Appearance of a fresh thrombus or intraluminal filling defects
* Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor)
* Cardiac intervention within 4 weeks of the procedure
* Severe renal insufficiency with eGFR\<30 ml/min/1.72 m2
* Congestive heart failure \[New York Heart Association (NYHA) Class III\\IV\] CSA Class IV
* Life expectancy \< 2 years due to other illnesses
* Acute or unstable medical disorder/disease that may cause a risk to patient, including:

i. Recent myocardial infarction (MI) (within the past two weeks) ii. Significant anemia (e.g. hemoglobin \< 8.0 mg / dl) iii. Recent major cerebrovascular event (history of stroke or TIA within 1 month) iv. Severe uncontrolled systemic hypertension (e.g., \>180/100 mmHg) v. Unstable angina requiring emergent percutaneous trans-luminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG)

Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No