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

NCT ID: NCT02477579

Last Updated: 2017-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-17
• Study Completion Date: 2017-08-10

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.

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.

Conditions

Chronic Total Occlusion of Coronary Artery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NovaCross

NovaCross microcatheter will be used.

Group Type: EXPERIMENTAL

NovaCross

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nitiloop Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simon Walsh, MD

Role: PRINCIPAL_INVESTIGATOR

Belfast Health and Social Care Trust

Locations

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, United States

Edward Hospital

Naperville, Illinois, United States

Columbia University Medical Center/New York Presbyterian Hospital

New York, New York, United States

York Hospital

York, Pennsylvania, United States

SPZOZ University Hospital in Krakow

Krakow, , Poland

Countries

United States; Poland

Other Identifiers

NT-CLP-01

Identifier Type: -

Identifier Source: org_study_id