A Prospective, First in Man Study to Evaluate the Safety and Performance of the NovaCross™ Micro-catheter in (CTO) Coronary Lesions

Chanan Schneider1 site in 1 country2 target enrollmentNovember 2013

ConditionsChronic Total Occlusion of Coronary Artery

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Total Occlusion of Coronary Artery
Sponsor: Chanan Schneider
Enrollment: 2
Locations: 1
Primary Endpoint: lack of device related major adverse event
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, non-randomized, first-in-man investigational study, to assess the safety and technical feasibility, deployment and withdrawal characteristics of the NovaCross™ micro-catheter during an interventional coronary angioplasty procedure and evaluating the CTO penetration rate.

Each study subject/patient will have a total of one (1) procedure performed for this study.

Detailed Description

To be filled later

Registry

clinicaltrials.gov

Start Date

November 2013

End Date

December 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chanan Schneider

Responsible Party

Sponsor Investigator

Principal Investigator

Chanan Schneider

COO

Nitiloop Ltd.

Eligibility Criteria

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
•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 with the following characteristics:
•Thrombolysis in Myocardial Infarction (TIMI) 0 flow for at least 90 days;
•Satisfactory distal vessel visualization
•CTO should be amenable to percutaneous treatment and must be located in a coronary vessel with a reference diameter of at least 2 millimeters.
•CTO refractory to a minimum of 10 minutes of conventional guide wire attempt.
•Body Mass Index (BMI) \< 40

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.
•Aorto-ostial CTO location (Ostial bifurcation origins may be considered), SVG CTO and in-stent CTOs.
•Intolerance to aspirin or Clopidogrel or Prasugrel or Ticagrelor medications
•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)
•Active gastrointestinal bleeding

Outcomes

Primary Outcomes

lack of device related major adverse event

Time Frame: 30 days

. 30-day Lack of device-related Major Adverse Cardiac Event Rate (MACE) at the site of target coronary lesion and/or its proximal reference segment. Time Frame: