NCT02477579

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
2 countries

5 active sites

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

May 17, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 17, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2017

Completed
Last Updated

August 17, 2017

Status Verified

August 1, 2017

Enrollment Period

2.2 years

First QC Date

June 17, 2015

Last Update Submit

August 14, 2017

Conditions

Chronic Total Occlusion of Coronary Artery

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • 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.)

    Procedure

  • Effectiveness of extendable portion (effectiveness of the extendable portion in intra-CTO microcatheter crossability)

    Procedure

  • Visualization (ability to have full visualization of the NovaCross during the CTO procedure)

    Procedure

  • Usability (Assess the usability of the NovaCross™ by the operator)

    Procedure

  • +1 more secondary outcomes

Study Arms (1)

NovaCross

EXPERIMENTAL

NovaCross microcatheter will be used.

Device: NovaCross

Interventions

NovaCrossDEVICE

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.

NovaCross

Eligibility Criteria

Age18 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 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%

You may not qualify if:

  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, 72205, United States

Location

Edward Hospital

Naperville, Illinois, 60540, United States

Location

Columbia University Medical Center/New York Presbyterian Hospital

New York, New York, 10032, United States

Location

York Hospital

York, Pennsylvania, 17403, United States

Location

SPZOZ University Hospital in Krakow

Krakow, Poland

Location

Study Officials

  • Simon Walsh, MD

    Belfast Health and Social Care Trust

    PRINCIPAL INVESTIGATOR

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

June 17, 2015

First Posted

June 23, 2015

Study Start

May 17, 2015

Primary Completion

August 10, 2017

Study Completion

August 10, 2017

Last Updated

August 17, 2017

Record last verified: 2017-08

Locations

PL(1)US(4)