NCT04862559

Brief Summary

This is an open label, single-center, prospective, pivotal study in which the investigational device, NovaCross™ micro-catheter, will be tested in up to 15 patients scheduled to undergo CTO-PCI using an anterograde approach.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2017

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
Last Updated

April 28, 2021

Status Verified

September 1, 2016

Enrollment Period

8 months

First QC Date

April 23, 2021

Last Update Submit

April 23, 2021

Conditions

Chronic Total Occlusion

Outcome Measures

Primary Outcomes (2)

  • Cardiovascular Adverse Events (Primary Safety)

    Accumulative incidence of Major Adverse Cardiovascular Events (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

  • Technical Success (Primary Efficacy)

    Intra-procedural technical success, defined as the ability of the NovaCross™ microcatheter to successfully facilitate placement of a guidewire beyond a native coronary chronic total occlusion in the true vessel lumen

    1 day

Secondary Outcomes (6)

  • Procedural Success

    1 day

  • Assistance in Guidewire Penetration

    1 day

  • Crossability

    1 day

  • Procedual Visualization

    1 day

  • Operator Ease of Use

    1 day

  • +1 more secondary outcomes

Study Arms (1)

NovaCross

EXPERIMENTAL

Subjects in this arm are treated with the investigational device, NovaCross micro-cetheter, to facilitate the opening of a chronic total occlusion (CTO)

Device: NovaCross

Interventions

NovaCrossDEVICE

A device that is intended to asisst interventional cardiologists during catheterization to cross and open coronary chronic total occlusions

NovaCross

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult aged 25-80
  • Patient understands and has signed the study informed consent form.
  • Patient is a suitable candidate for non-emergent, coronary angioplasty
  • Patient has an angiographic documented Chronic Total Occlusion (i.e. \>3 months occlusion duration either by documentation or PI assessment Investigator) showing distal TIMI flow 0.
  • Coronary angiography of CTO lesion reveals satisfactory distal vessel visualization
  • CTO lesion is located in a coronary vessel with a reference diameter of at least 2 millimeters.
  • CTO lesion is suitable for antegrade approach.
  • Left ventricle ejection fraction \> 25%
  • Body Mass Index (BMI) \< 40

You may not qualify if:

  • Patient unable to give informed consent.
  • Patient is participating 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.
  • 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 (stroke or TIA within 30 days)
  • Significant anemia (hemoglobin \< 8.0 mg / dl)
  • 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)
  • Unwillingness or inability to comply with any protocol requirements
  • Pregnancy or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Szpital Uniwersytecki w Krakowie

Krakow, Poland

Location

Study Officials

  • Chanan Schneider, Mr.

    Company Employee

    STUDY DIRECTOR

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

April 23, 2021

First Posted

April 28, 2021

Study Start

February 1, 2017

Primary Completion

September 17, 2017

Study Completion

September 17, 2017

Last Updated

April 28, 2021

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)