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

Chronic Total Occlusion of Coronary Artery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02477579
• Other study ID #: NT-CLP-01
• Status: Completed
• Phase: N/A
• First received: June 17, 2015
• Last updated: August 14, 2017
• Start date: May 17, 2015
• Est. completion date: August 10, 2017

Study information

• Verified date: August 2017
• Source: Nitiloop Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: August 10, 2017
• Est. primary completion date: August 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Total Occlusion of Coronary Artery

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Poland	SPZOZ University Hospital in Krakow	Krakow
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Nitiloop Ltd.

Countries where clinical trial is conducted

United States,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	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
Secondary	Proximal cap (ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO.)	2. The ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO.	Procedure
Secondary	Effectiveness of extendable portion (effectiveness of the extendable portion in intra-CTO microcatheter crossability)	3. The effectiveness of the extendable portion in intra-CTO microcatheter crossability.	Procedure
Secondary	Visualization (ability to have full visualization of the NovaCross during the CTO procedure)	4. The ability to have full visualization of the NovaCross during the CTO procedure.	Procedure
Secondary	Usability (Assess the usability of the NovaCross™ by the operator)	5. Assess the usability of the NovaCross™ by the operator.	Procedure
Secondary	Device-related perforation (at the site of target coronary lesion and/or its proximal reference segment)	6. Device-related perforation at the site of target coronary lesion and/or its proximal reference segment.	Procedure